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CAMBRIDGE, MASS. & OSAKA, JAPAN--( / ) December 17, 2018 -- Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the extension of the marketing authorization of ADCETRIS (brentuximab vedotin) and recommended its approval in combination with AVD in adult patients with previously untreated CD30+ Stage IV Hodgkin lymphoma. ADCETRIS is an antibody-drug conjugate (ADC) directed at CD30, a defining marker of Hodgkin lymphoma. ADCETRIS is currently not approved as a therapy for previously untreated Hodgkin lymphoma in Europe.

“For a large number of previously untreated Hodgkin lymphoma patients diagnosed with Stage IV disease, progression will occur with current treatments, highlighting a true unmet need in this population,” said Anna Sureda, M.D., Ph.D., Head of the Hematology Department and Hematopoietic Stem Cell Transplant Programme, Institut Catala d'Oncologia - Hospital Duran i Reynals. “In the ECHELON-1 clinical trial, ADCETRIS in combination with AVD reduced the risk of progression, death or need for subsequent anticancer therapy in patients with Stage IV disease by 29 percent versus ABVD, a standard of care. If approved in this indication, ADCETRIS may offer an important novel treatment option for previously untreated patients with Stage IV Hodgkin lymphoma in Europe.”

“Today’s positive CHMP opinion represents a significant step forward for the European Hodgkin lymphoma community,” said Jesus Gomez-Navarro, M.D., Vice President, Head of Oncology Clinical Research and Development, Takeda. “The results of the ECHELON-1 trial demonstrated a statistically significant improvement in modified progression-free survival of in patients who received ADCETRIS in combination with AVD compared to the control arm. In addition to demonstrating a safety profile that was generally consistent with that known for the single-agent components of the regimen, in the ADCETRIS containing arm, 35 percent fewer patients with Stage IV disease received subsequent salvage chemotherapy or high-dose chemotherapy and transplant. We look forward to the European Commission’s review of this CHMP positive opinion and hope to offer ADCETRIS as a treatment option to appropriate European Hodgkin lymphoma patients in the future.”

The submission for ADCETRIS will now be reviewed by the European Commission (EC), which has the authority to approve medicines for use in the 28-member states of the European Union (EU). Decisions by the EC are also applicable in Norway, Liechtenstein and Iceland.

The positive CHMP opinion is based on the results of the Phase 3 ECHELON-1 study designed to compare ADCETRIS plus AVD to ABVD as a therapy in adult patients with previously untreated Hodgkin lymphoma. The trial achieved its primary endpoint resulting in a statistically significant improvement in modified progression-free survival (PFS) versus the control arm (HR 0.77; p-value=0.035). Key subgroup analyses, such as modified PFS by disease stage, showed a larger effect in patients with Stage IV Hodgkin lymphoma in the ADCETRIS plus AVD arm versus the control arm (HR 0.71; p-value = 0.023). This corresponds to a 29 percent reduction in the risk of progression, death or need for additional anticancer therapy for Stage IV patients.

About the ECHELON-1 Trial

The randomized, open-label, two-arm, multi-center Phase 3 ECHELON-1 trial achieved its primary endpoint with the combination of ADCETRIS+AVD resulting in a statistically significant improvement in modified progression-free survival (PFS) versus the control arm of ABVD as assessed by an Independent Review Facility (IRF) (HR 0.77; p-value=0.035). This corresponds to a 23 percent reduction in the risk of progression, death or need for additional anticancer therapy.

· All secondary endpoints trended in favor of the ADCETRIS+AVD arm, including interim analysis of overall survival (OS; HR 0.72; p-value=0.19).

· In the ADCETRIS+AVD arm, 33 percent fewer patients received subsequent salvage chemotherapy or high-dose chemotherapy and transplant.

· The safety profile of ADCETRIS+AVD in the ECHELON-1 trial was generally consistent with that known for the single-agent components of the regimen.

· The most common clinically relevant adverse events of any grade that occurred in at least 15 percent of patients in the ADCETRIS+AVD and ABVD arms were: neutropenia, constipation, vomiting, fatigue, peripheral sensory neuropathy, diarrhea, pyrexia, peripheral neuropathy, abdominal pain and stomatitis. In both the ADCETRIS+AVD and ABVD arms, the most common Grade 3 or 4 events were neutropenia, febrile neutropenia and neutrophil count decrease.

About Hodgkin Lymphoma

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. The Reed-Sternberg cell expresses CD30.

According to the Lymphoma Coalition, approximately 67,000 people worldwide are diagnosed with Hodgkin lymphoma each year and more than 25,000 people die each year from this cancer.

Up to 30 percent of previously untreated Hodgkin lymphoma patients progress following their first therapy depending on the stage of the disease. Only 50 percent of patients with relapsed or refractory Hodgkin lymphoma achieve long-term remission with high-dose chemotherapy and an autologous stem cell transplant (ASCT), a historically used treatment regimen, highlighting the need for successful treatments for previously untreated patients.

About ADCETRIS

ADCETRIS is an antibody-drug conjugate (ADC) comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-positive tumor cells.

ADCETRIS injection for intravenous infusion has received FDA approval for six indications in adult patients with: (1) previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone, (2) previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine, (3) cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (4) cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (5) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (6) primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL in 2013, and non-conditional approval for post-autologous stem cell transplant (ASCT) consolidation treatment of Hodgkin lymphoma patients at increased risk of relapse or progression.

ADCETRIS received conditional marketing authorization from the European Commission in October 2012. The approved indications in Europe are: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (2) the treatment of adult patients with relapsed or refractory sALCL, (3) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, and (4) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

ADCETRIS has received marketing authorization by regulatory authorities in more than 70 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See important safety information below.

ADCETRIS is being evaluated broadly in more than 70 clinical trials, including a Phase 3 study in first-line Hodgkin lymphoma (ECHELON-1) and another Phase 3 study in first-line CD30-positive peripheral T-cell lymphomas (ECHELON-2), as well as trials in many additional types of CD30-positive malignancies.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

ADCETRIS (brentuximab vedotin) Important Safety Information (European Union)

Please refer to Summary of Product Characteristics (SmPC) before prescribing.

CONTRAINDICATIONS

ADCETRIS is contraindicated for patients with hypersensitivity to brentuximab vedotin and its excipients. In addition, combined use of ADCETRIS with bleomycin causes pulmonary toxicity.

SPECIAL WARNINGS & PRECAUTIONS

Progressive multifocal leukoencephalopathy (PML): John Cunningham virus (JCV) reactivation resulting in progressive multifocal leukoencephalopathy (PML) and death can occur in patients treated with ADCETRIS. PML has been reported in patients who received ADCETRIS after receiving multiple prior chemotherapy regimens. PML is a rare demyelinating disease of the central nervous system that results from reactivation of latent JCV and is often fatal.

Closely monitor patients for new or worsening neurological, cognitive, or behavioral signs or symptoms, which may be suggestive of PML. Suggested evaluation of PML includes neurology consultation, gadolinium-enhanced magnetic resonance imaging of the brain, and cerebrospinal fluid analysis for JCV DNA by polymerase chain reaction or a brain biopsy with evidence of JCV. A negative JCV PCR does not exclude PML. Additional follow up and evaluation may be warranted if no alternative diagnosis can be established Hold dosing for any suspected case of PML and permanently discontinue ADCETRIS if a diagnosis of PML is confirmed.

Be alert to PML symptoms that the patient may not notice (e.g., cognitive, neurological, or psychiatric symptoms).

Pancreatitis: Acute pancreatitis has been observed in patients treated with ADCETRIS. Fatal outcomes have been reported. Closely monitor patients for new or worsening abdominal pain, which may be suggestive of acute pancreatitis. Patient evaluation may include physical examination, laboratory evaluation for serum amylase and serum lipase, and abdominal imaging, such as ultrasound and other appropriate diagnostic measures. Hold ADCETRIS for any suspected case of acute pancreatitis. ADCETRIS should be discontinued if a diagnosis of acute pancreatitis is confirmed.

Pulmonary Toxicity: Cases of pulmonary toxicity, some with fatal outcomes, including pneumonitis, interstitial lung disease, and acute respiratory distress syndrome (ARDS), have been reported in patients receiving ADCETRIS. Although a causal association with ADCETRIS has not been established, the risk of pulmonary toxicity cannot be ruled out. Promptly evaluate and treat new or worsening pulmonary symptoms appropriately. Consider holding dosing during evaluation and until symptomatic improvement.

Serious infections and opportunistic infections: Serious infections such as pneumonia, staphylococcal bacteremia, sepsis/septic shock (including fatal outcomes), and herpes zoster, and opportunistic infections such as Pneumocystis jiroveci pneumonia and oral candidiasis have been reported in patients treated with ADCETRIS. Carefully monitor patients during treatment for emergence of possible serious and opportunistic infections.

Infusion-related reactions (IRR): Immediate and delayed IRR, as well as anaphylaxis, have occurred with ADCETRIS. Carefully monitor patients during and after an infusion. If anaphylaxis occurs, immediately and permanently discontinue administration of ADCETRIS Appropriate medical therapy should be administered. If an IRR occurs, interrupt the infusion and institute appropriate medical management. The infusion may be restarted at a slower rate after symptom resolution. Patients who have experienced a prior IRR should be premedicated for subsequent infusions. IRRs are more frequent and more severe in patients with antibodies to ADCETRIS.

Tumor lysis syndrome (TLS): TLS has been reported with ADCETRIS. Patients with rapidly proliferating tumor and high tumor burden are at risk of TLS. Monitor these patients closely and managed according to best medical practice.

Peripheral neuropathy (PN): ADCETRIS treatment may cause PN, both sensory and motor. ADCETRIS-induced PN is typically cumulative and reversible in most cases. Monitor patients for symptoms of PN, such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain, or weakness. Patients experiencing new or worsening PN may require a delay and a dose reduction or discontinuation of ADCETRIS.

Hematological toxicities: Grade 3 or Grade 4 anemia, thrombocytopenia, and prolonged (equal to or greater than one week) Grade 3 or Grade 4 neutropenia can occur with ADCETRIS. Monitor complete blood counts prior to administration of each dose.

Febrile neutropenia: Febrile neutropenia has been reported. Closely monitor patients for fever and manage according to best medical practice if febrile neutropenia develops.

Stevens-Johnson syndrome (SJS): SJS and toxic epidermal necrolysis (TEN) have been reported with ADCETRIS. Fatal outcomes have been reported. Discontinue treatment with ADCETRIS if SJS or TEN occurs and administer appropriate medical therapy.

Gastrointestinal (GI) Complications: GI complications, some with fatal outcomes, including intestinal obstruction, ileus, enterocolitis, neutropenic colitis, erosion, ulcer, perforation and haemorraghe, have been reported. Promptly evaluate and treat patients if new or worsening GI symptoms occur.

Hepatotoxicity: Elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) have been reported. Serious cases of hepatotoxicity, including fatal outcomes, have also occurred. Test liver function prior to treatment initiation and routinely monitor patients receiving ADCETRIS for liver elevations. Patients experiencing hepatotoxicity may require a delay, dose modification, or discontinuation of ADCETRIS.

Hyperglycemia: Hyperglycemia has been reported during trials in patients with an elevated body mass index (BMI) with or without a history of diabetes mellitus. Closely monitor serum glucose for patients who experiences an event of hyperglycemia. Administer anti-diabetic treatment as appropriate.

Renal and Hepatic Impairment: There is limited experience in patients with renal and hepatic impairment. Available data indicate that MMAE clearance might be affected by severe renal impairment, hepatic impairment, and by low serum albumin concentrations.

CD30+ CTCL: The size of the treatment effect in CD30 + CTCL subtypes other than mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL) is not clear due to lack of high level evidence. In two single arm phase II studies of ADCETRIS, disease activity has been shown in the subtypes Sezary syndrome (SS), lymphomatoid papulosis (LyP) and mixed CTCL histology. These data suggest that efficacy and safety can be extrapolated to other CTCL CD30+ subtypes. Carefully consider the benefit-risk per patient and use caution in other CD30+ CTCL patient types.

Sodium content in excipients: ADCETRIS contains a maximum of 2.1 mmol (or 47 mg) of sodium per dose. Take this into consideration for patients on a controlled sodium diet.

INTERACTIONS

Patients who are receiving a strong CYP3A4 and P-gp inhibitor, concomitantly with ADCETRIS may have an increased risk of neutropenia and should be closely monitored. Co-administration of ADCETRIS with a CYP3A4 inducer did not alter the plasma exposure of ADCETRIS but it appeared to reduce plasma concentrations of MMAE metabolites that could be assayed. ADCETRIS is not expected to alter the exposure to drugs that are metabolized by CYP3A4 enzymes.

PREGNANCY: Advise women of childbearing potential to use two methods of effective contraception during treatment with ADCETRIS and until 6 months after treatment. There are no data from the use of ADCETRIS in pregnant women, although studies in animals have shown reproductive toxicity. Do not use ADCETRIS during pregnancy unless the benefit to the mother outweighs the potential risks to the fetus.

LACTATION (breast-feeding): There are no data as to whether ADCETRIS or its metabolites are excreted in human milk, therefore a risk to the newborn/infant cannot be excluded. With the potential risk, a decision should be made whether to discontinue breast-feeding or discontinue/abstain from therapy with ADCETRIS.

FERTILITY: In nonclinical studies, ADCETRIS treatment has resulted in testicular toxicity, and may alter male fertility. Advise men being treated with ADCETRIS not to father a child during treatment and for up to 6 months following the last dose.

Effects on ability to drive and use machines: ADCETRIS may have a minor influence on the ability to drive and use machines.

UNDESIRABLE EFFECTS

The most frequent adverse reactions (≥10%) were infections, peripheral sensory neuropathy, nausea, fatigue, diarrhoea, pyrexia, upper respiratory tract infection, neutropenia, rash, cough, vomiting, arthralgia, peripheral motor neuropathy, infusion-related reactions, pruritus, constipation, dyspnoea, weight decreased, myalgia and abdominal pain.

Serious adverse drug reactions were: pneumonia, acute respiratory distress syndrome, headache, neutropenia, thrombocytopenia, constipation, diarrhea, vomiting, nausea, pyrexia, peripheral motor neuropathy, peripheral sensory neuropathy, hyperglycemia, demyelinating polyneuropathy, tumor lysis syndrome, and Stevens-Johnson syndrome. Serious adverse drug reactions occurred in 12% of patients. The frequency of unique serious adverse drug reactions was ≤1%.

ADCETRIS (brentuximab vedotin) Important Safety Information (U.S.)

BOXED WARNING: PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML):

JC virus infection resulting in PML and death can occur in ADCETRIS-treated patients.

Contraindication

ADCETRIS concomitant with bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation).

Warnings and Precautions

· Peripheral neuropathy (PN): ADCETRIS causes PN that is predominantly sensory. Cases of motor PN have also been reported. ADCETRIS-induced PN is cumulative. Monitor for symptoms such as hypoesthesia, hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic pain, or weakness. Institute dose modifications accordingly.

· Anaphylaxis and infusion reactions: Infusion-related reactions (IRR), including anaphylaxis, have occurred with ADCETRIS. Monitor patients during infusion. If an IRR occurs, interrupt the infusion and institute appropriate medical management. If anaphylaxis occurs, immediately and permanently discontinue the infusion and administer appropriate medical therapy. Premedicate patients with a prior IRR before subsequent infusions. Premedication may include acetaminophen, an antihistamine, and a corticosteroid.

· Hematologic toxicities: Fatal and serious cases of febrile neutropenia have been reported with ADCETRIS. Prolonged (≥1 week) severe neutropenia and Grade 3 or 4 thrombocytopenia or anemia can occur with ADCETRIS. Start primary prophylaxis with G-CSF beginning with Cycle 1 for patients who receive ADCETRIS in combination with chemotherapy for previously untreated Stage III or IV classical HL or previously untreated PTCL. Monitor complete blood counts prior to each ADCETRIS dose. Monitor more frequently for patients with Grade 3 or 4 neutropenia. Monitor patients for fever. If Grade 3 or 4 neutropenia develops, consider dose delays, reductions, discontinuation, or G-CSF prophylaxis with subsequent ADCETRIS doses.

· Serious infections and opportunistic infections: Infections such as pneumonia, bacteremia, and sepsis or septic shock (including fatal outcomes) have been reported in ADCETRIS-treated patients. Closely monitor patients during treatment for bacterial, fungal, or viral infections.

· Tumor lysis syndrome: Closely monitor patients with rapidly proliferating tumor and high tumor burden.

· Increased toxicity in the presence of severe renal impairment: The frequency of ≥Grade 3 adverse reactions and deaths was greater in patients with severe renal impairment compared to patients with normal renal function. Avoid use in patients with severe renal impairment.

· Increased toxicity in the presence of moderate or severe hepatic impairment: The frequency of ≥Grade 3 adverse reactions and deaths was greater in patients with moderate or severe hepatic impairment compared to patients with normal hepatic function. Avoid use in patients with moderate or severe hepatic impairment.

· Hepatotoxicity: Fatal and serious cases have occurred in ADCETRIS-treated patients. Cases were consistent with hepatocellular injury, including elevations of transaminases and/or bilirubin, and occurred after the first ADCETRIS dose or rechallenge. Preexisting liver disease, elevated baseline liver enzymes, and concomitant medications may increase the risk. Monitor liver enzymes and bilirubin. Patients with new, worsening, or recurrent hepatotoxicity may require a delay, change in dose, or discontinuation of ADCETRIS.

· PML: Fatal cases of JC virus infection resulting in PML and death have been reported in ADCETRIS-treated patients. First onset of symptoms occurred at various times from initiation of ADCETRIS therapy, with some cases occurring within 3 months of initial exposure. Other possible contributory factors other than ADCETRIS include prior therapies and underlying disease that may cause immunosuppression. Consider PML diagnosis in patients with new-onset signs and symptoms of central nervous system abnormalities. Hold ADCETRIS if PML is suspected and discontinue ADCETRIS if PML is confirmed.

· Pulmonary toxicity: Fatal and serious events of noninfectious pulmonary toxicity including pneumonitis, interstitial lung disease, and acute respiratory distress syndrome have been reported. Monitor patients for signs and symptoms, including cough and dyspnea. In the event of new or worsening pulmonary symptoms, hold ADCETRIS dosing during evaluation and until symptomatic improvement.

· Serious dermatologic reactions: Fatal and serious cases of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) have been reported with ADCETRIS. If SJS or TEN occurs, discontinue ADCETRIS and administer appropriate medical therapy.

· Gastrointestinal (GI) complications: Fatal and serious cases of acute pancreatitis have been reported. Other fatal and serious GI complications include perforation, hemorrhage, erosion, ulcer, intestinal obstruction, enterocolitis, neutropenic colitis, and ileus. Lymphoma with preexisting GI involvement may increase the risk of perforation. In the event of new or worsening GI symptoms, perform a prompt diagnostic evaluation and treat appropriately.

· Embryo-fetal toxicity: Based on the mechanism of action and animal studies, ADCETRIS can cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus, and to avoid pregnancy during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS.

Most Common (≥20% in any study) Adverse Reactions: Peripheral neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, pyrexia, constipation, vomiting, alopecia, decreased weight, abdominal pain, anemia, stomatitis, lymphopenia and mucositis.

Drug Interactions

Concomitant use of strong CYP3A4 inhibitors or inducers has the potential to affect the exposure to monomethyl auristatin E (MMAE).

Use in Specific Populations

Moderate or severe hepatic impairment or severe renal impairment: MMAE exposure and adverse reactions are increased. Avoid use.

Advise males with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS.

Advise patients to report pregnancy immediately and avoid breastfeeding while receiving ADCETRIS.

For additional Important Safety Information, including BOXED WARNING, please see the full Prescribing Information for ADCETRIS at or

About Takeda Pharmaceutical Company

Takeda Pharmaceutical Company Limited (TSE: 4502) is a global, research and development-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its R&D efforts on oncology, gastroenterology and neuroscience therapeutic areas plus vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. Innovative products, especially in oncology and gastroenterology, as well as Takeda’s presence in emerging markets, are currently fueling the growth of Takeda. Approximately 30,000 Takeda employees are committed to improving quality of life for patients, working with Takeda’s partners in health care in more than 70 countries.

For more information, visit

Additional information about Takeda is available through its corporate website, , and additional information about Takeda Oncology, the brand for the global oncology business unit of Takeda Pharmaceutical Company Limited, is available through its website,

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프릴리지복제약 소액투자자 장기동가라오케 마곡동키스방 잠실동토킹bar 우츠노미야시온 온파인넷 로또추천사이트 AV노리야동 vagina 온라인게임 덕지동풀싸롱 신림출장마사지│도봉출장마사지│노원출장마사지 대림동안마 오또맘 각리그득점랭킹 여자패션블로그 가정교사오시마나기사 배관롤러 증명사진수정 이사동나이트 엄마자위 하왕십리동방석집 8월인기가수 자운동토킹bar 서양누드 구산오피 워런트매매 토토알바 오에1080 채권투자 갈현동안마 렌터카창업 바카라3만쿠폰 마진 하남풀싸롱 노모자이크야한동영상 PORN 전효성d컵 급등주 섹스사이트 용산동대딸방 브레지어하고계세요 다가동모바일홀덤 캐논슈터폭업사냥터 샤인주식 자운동떡집 팬코스프레 상호저축은행대출 여자친구를일진짱에게빌려주다 은행동텍사스홀덤 스코어888 장미인애90분 마이지식보기 거래량급등 gangbang 안노히데아키 디스코팡팡묘기 한일화학주식 포도닷컴 일직동홀덤카페 설악면포커고수 아오이유우몸무게 상대동퍼블릭룸 한국아이돌가수 리한나 몸매좋은아이돌 경포대비키니 우장산동홀덤대회 여자선생님 토렌트롱 부전동성인인형체험 완이만 노량진1동홀덤대회 통인동토킹bar 신정동안마 이특정수정 단구동카지노펍 티아라바탕화면 발렌시아가가방핸드백 안암동5가오마하홀덤 비스트웃긴동영상 종근당바이오주식 강예빈트러블메이커 개미들닷컴 프리바디 카라백 당산동1가포커고수 상면홀덤바 창동유흥문화 박민영속옷화보 풍남동홀덤족보 한소영성형전 인화동홀덤펍 동명동홀덤바 보배넷 한그루위치걸가사 가수원동성인게임장 성인용품구매 최근기사 http://xn--2i0bm4pt5h46g67b.com 재송동키스방 청학동오마하홀덤 베리얀30 로또복권행운번호 섹시화보글래머글래머사진 애프터스쿨디바뮤비 영동나이트 이종현복근 신정동건마 무한도전영어마을 maturesex 유양동건마 새 내귀에도청장치1집 지지미 홍제동텍사스홀덤 영국여자 남문동카지노펍 나운동인싸포커 노은동리얼돌성인인형 감만동리얼돌성인인형 중촌동립카페 엣지나라 멋진배경사진 관문동성인인형체험 신흥동홀덤펍 akb49 야마토통기계버전 연남동홀덤바 야애니 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슈퍼박테리아 서대문성인게임장 명장동룸싸롱 월계동출장마사지 추천떡집 청라면레깅스룸 동호동포커고수 안유정 레인보우a자동재생 은행동성인인형체험 문원동성인오락실 현아아이스크림듣기 부창동룸싸롱 근화동카지노펍 케이에스피주식 씨스타socool안무 섹스앤더시티시즌2 장염설사 법률구조제도 가평홀덤대회 동산동성인오락실 입암면인싸포커 축구픽 만성동홀덤펍 세계피겨선수권대회중계 돌체앤가바나카드지갑 안티이명박 문지동대딸방 kbs뉴스다시보기 html이미지링크 완전성인방송 빈티지란 셀트리온주식 영등포동2가홀덤카페 농구분석 신기면홀덤바 휘석 미소알바 설악동인싸포커 그리기쉬운연예인사진 반송동립카페 중앙동홀덤룰 현빈국군방송 월계동카지노펍 사당5동홀덤룰 소라넷ㅅ 강동구대딸방 대림3동홀덤펍 모지미림에스포르케클럽 삼천동성인게임장 몰몬교연예인 kbs다시보기 http://q-sportstoto.com 가평읍홀덤카페 티파니목걸이가격 샤넬지갑신상 일구핫 행촌동홀덤룰 섹시비키니화보 아이유섹시 용계동오마하홀덤 세동풀싸롱 bj쪼꼬북 효자동포커고수 여학생닷컴 등촌3동성인오락실 수지뱃살 섹시누드 고야드 심곡동성인오락실 디시인사이드북한 스포츠투데이 상도4동인싸포커 게임불카누스 인후동홀덤대회 소양로모바일홀덤 김태희공부법 오페르스가드 주암동홀덤바 힙합비트 근덕면성인오락실 이해인움짤 스포츠토토카페 이미지사진가격 이부진결혼 신도림동홀덤룰 역삼동퍼블릭룸 관고동성인오락실 성인동영상ㅋ 신대양제지주식 아프리카d컵 버버리패딩 통일교연예인 지연코딱지 권선구안마 하월곡동홀덤룰 국제약품주식 해외승무패 고추만져주기 일본av이름 마크제이콥스웰링턴백 jpsex 원문동성인인형체험 싸이고향 아디다스남자수영복 교하동룸싸롱 일본맹렬간호학원 여자화장실그림 일본av비디오 노량진동텍사스홀덤 병점동노래방 봉산동오피 해외축구스코어 청당동유흥거리 씨름선수 신성통상주식 연예인섹시화보 SeRsEriDeLiKaN 신방동나이트 티비왕 대현동성인오락실 문원동오마하홀덤 서교동성인게임장 슈에무라베이스 플렉스컴주식 반정동텍사스홀덤 대림동유흥문화 2012-2013 프로농구 쇼콜라뜻 하늘사랑 검산동모바일홀덤 잠실동유흥문화 신인아이돌악보 고천동카지노펍 별양동방석집 캐릭터양말 청운동성인게임장 도곡2동카지노펍 방화2동성인게임장 STX조선해양분석 현대캐피탈대출영업 이혜영 먹튀신고 소니psp 절박성요실금 용산psp 허재훈집안 하왕십리동립카페 의료용접착제 문스탁 중화동나이트 고딩각선미 정치인테마주 슬롯머신주소 비타민A연고 오르가즘동영상 DMCA불만사항 사설먹튀검증 7MSPORT 코스피 애니다스 양음양패턴 월계동키스방 로또판매점공고 화지동성인게임장 떡마차링크 야동다운 청평면풀싸롱 일본남자아이돌쩌는목소리 불당동풀싸롱 마구마구넷 남자발리벨트 먹튀폴리스아레나 장전동성인용품 야한자료 당정동대딸방 학의동성인용품 주니치[1이닝득점] 제주경마장가는길 성북동레깅스룸 동안구룸싸롱 일본아이돌성매매 모바일바둑 백석동퍼블릭룸 검상동나이트 쿨김성수 노출화보민간인 토토홍보커뮤니티 584회로또당첨번호 텐가 선구용품 귀요미송트렌스젠더 언더웨어쇼핑몰 골반교정스트레칭 먹튀폴리스검증업체 가슴확대수술전후사진 미우미우 피망게임이안되요 토토검증커뮤니티 일본로또사이트 친환경면생리대 5년적금 http://powerball-e.com 용산동나이트 매노동출장마사지 업성동오피 불가리벨트 바다스톰릴갬 슈어맨해태 초등학생공부사이트 축구승무패분석 순천유흥주점 아들녀석들리지 박거성 오토렌트 LIVE69TV 영통동레깅스룸 토토보증업체 애니 여자과다노출 sportsbetting 섹쉬한여자 전신경락마사지 구찌썬글라스 스캇리치몬드 망월동떡집 부부크리닉 신대동토킹bar 당산동오피 천호동떡집 소녀시대보고있나 복용동성인용품 http://blackgambler1.com 성인코스프레 자흉침 여성을위한콘돔 박진주 뜨거운형제들이기광 비키니시즌오프 수원시장안구대딸방 싸고넷 도선동토킹bar javhdmovies 인스타아지트샵 야한치마 남현동유흥문화 슈퍼맨리턴즈
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