Takeda to Highlight Broad Oncology Portfolio and Pipeline Data at the American Society of Clinical Oncology (ASCO) and the Congress of the European Hematology Association (EHA) Annual Meetings

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CAMBRIDGE, Mass. & OSAKA, Japan--(BUSINESS WIRE)--May 17, 2018--Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the company will feature a total of 14 Takeda Oncology-sponsored presentations at two upcoming medical meetings: the 54th Annual Meeting of the American Society of Clinical Oncology (ASCO), June 1-5 in Chicago and the 23rd Congress of the European Hematology Association (EHA), June 14-17 in Stockholm. This year’s presentations will underscore Takeda’s unwavering pursuit to advance hematologic cancer therapy and continue building upon research in difficult-to-treat solid tumors.

“At ASCO and EHA we will present data, real-world findings and trial updates on our pipeline assets as well as our marketed therapies,” said Christophe Bianchi, M.D., President, Takeda Oncology. “At ASCO, we will present updated Phase 2 ALTA trial results examining long-term efficacy and safety of ALUNBRIG in patients with ALK+ non-small cell lung cancer who are refractory to crizotinib. Notably, at EHA we will present data on pre-specified subgroups from the ECHELON-1 Phase 3 trial evaluating a combination with ADCETRIS as a frontline treatment for patients with Hodgkin lymphoma. Takeda’s research continues to push innovation in oncology to advance needed treatments and illustrates the company’s vision to improve the lives of cancer patients.”

At this year’s ASCO meeting, updated Phase 2 ALTA ( A LK in L ung Cancer T rial of A P26113) trial results examining long-term efficacy and safety of ALUNBRIG ® (brigatinib) in a crizotinib refractory anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) population will be presented. During the poster discussion presentations, TAK-788, a small molecule tyrosine kinase inhibitor targeting the epidermal growth factor receptor (EGFR) and human epidermal growth factor receptor 2 (HER2) mutations, including exon 20 insertions, will report on the safety, pharmacokinetics and preliminary antitumor activity of this molecule in NSCLC patients. In addition, results from a first-in-human Phase 1 study of TAK-931, a small molecule inhibitor of the CDC7 kinase activity, in patients with advanced solid tumors will be shared during the oral presentations. The trial, which investigates the effect of TAK-931 in up to 100 participants with solid tumors, examines the safety, tolerability and pharmacokinetics of the oral medication to determine the maximum tolerated dose.

The company also continues to deepen its scientific body of knowledge in hematologic cancers. At ASCO, the company will present a “Trials in Progress” poster on the ongoing randomized global Phase 3 trial, PANTHER (investigational intravenous P evonedistat plus A zacitidi n e versus single-agent azacitidine as first-line T reatment for patients with H igh e r- R isk myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia or low-blast acute myelogenous leukemia (AML)).

Furthermore, at this year’s EHA meeting, data on the efficacy and safety of a combination with ADCETRIS ® (brentuximab vedotin) in pre-specified subgroups with more advanced disease from the ECHELON-1 trial will be presented. Data demonstrate greater benefit across these subgroups compared to the intent to treat population regardless of PET2 status based on the primary endpoint of modified progression-free survival. In addition, encore data from the Phase 3 ECHELON-1 clinical trial evaluating ADCETRIS as part of a frontline combination chemotherapy regimen in previously untreated advanced stage Hodgkin lymphoma will be featured. The data was previously presented in the Plenary Session at the 59th American Society of Hematology (ASH) Annual Meeting in December 2017. Finally, a study of TAK-659, a reversible dual inhibitor of spleen tyrosine kinase (SYK) and FMS-like tyrosine kinase-3 (FLT3), in combination with standard of care treatments will present preliminary safety and efficacy data in diffuse large B-cell lymphoma models.

Safety, efficacy and real-world use findings from Takeda Oncology-sponsored trials examining a variety of blood cancers, including lymphoma, multiple myeloma and MDS, will be featured at ASCO and / or EHA.

The six Takeda Oncology-sponsored abstracts accepted for presentation during ASCO 2018 and eight abstracts at EHA 2018 include:

ASCO Annual Meeting 2018

Note: All times listed are in Central Daylight Time

ADCETRIS (brentuximab vedotin)

Brentuximab Vedotin with Chemotherapy for Stage III or IV Hodgkin Lymphoma (HL): Impact of Cycle 2 PET Result on Modified Progression-Free Survival. Abstract 7539. Monday, June 4, 8:00-11:30 a.m., Hall A. Improving Outcomes with Brentuximab Vedotin (BV) plus Chemotherapy in Patients with Newly Diagnosed Advanced Stage Hodgkin Lymphoma. Abstract 7534. Monday, June 4, 8:00-11:30 a.m., Hall A.

ALUNBRIG (brigatinib)

Brigatinib (BRG) in Crizotinib (CRZ)-Refractory ALK+ Non–Small Cell Lung Cancer (NSCLC): Efficacy Updates and Exploratory Analysis of CNS ORR and Overall ORR by Baseline (BL) Brain Lesion Status. Abstract 9061. Sunday, June 3, 8:00-11:30 a.m., Hall A.

Pipeline

First-in-Human Phase 1 Study of TAK-931, an Oral Cell Division Cycle 7 (CDC7) Inhibitor in Patients (Pts) with Advanced Solid Tumors. Abstract 2506. Oral presentation. Friday, June 1, 4:09-4:21 p.m., S406. First Report of Safety, PK and Preliminary Antitumor Activity of the Oral EGFR/HER2 Exon 20 Inhibitor TAK-788 (AP32788) in Non–Small Cell Lung Cancer (NSCLC). Abstract 9015. Sunday, June 3, 11:30 a.m.-12:45 p.m., Hall A. Phase 3 Study of First Line Pevonedistat (PEV) + Azacitidine (AZA) versus Single-Agent AZA in Patients with Higher-Risk Myelodysplastic Syndromes (HR MDS), Chronic Myelomonocytic Leukemia (CMML) or Low-Blast Acute Myelogenous Leukemia (AML). Abstract TPS7077. Monday, June 4, 8:00-11:00 a.m., Hall A.

EHA 23rd Congress

Note: All times listed are in Central European Time

ADCETRIS (brentuximab vedotin)

Brentuximab Vedotin Plus Chemotherapy in High Risk Advanced-Stage Classical Hodgkin Lymphoma (CHL) Patients: Results of Pre-Specified Sub-Group Analyses from the ECHELON-1 Study. Abstract S112. Oral presentation. Friday, June 15, 12:00-12:15 p.m., Room A2. Brentuximab Vedotin with Chemotherapy for Stage III or IV Hodgkin Lymphoma: Impact of Cycle2 PET Modified Progression-Free Survival. Abstract PS1172. Saturday, June 16, 5:30-7:00 p.m., Poster Area. Frontline Brentuximab Vedotin Plus Chemotherapy Exhibits Superior Modified Progression-Free Survival vs Chemotherapy Alone in Patients with Stage III or IV Hodgkin Lymphoma: Phase 3 ECHELON-1 Study. Abstract PS1182. Saturday, June 16, 5:30-7:00p.m., Poster Area. Brentuximab Vedotin in Relapsed/Refractory Systemic Anaplastic Large-Cell Lymphoma: A Cost-Effectiveness Analysis. Abstract PF684. Friday, June 15, 5:30-7:00 p.m., Poster Area.

NINLARO (ixazomib)

A Global Treatment Standard in Multiple Myeloma (MM) Remains Elusive Despite Advances in Care Over 15 Years: First Results from INSIGHT MM, the Largest Global Prospective, Observational MM Study. Abstract PS1300. Saturday, June 16, 5:30-7:00 p.m., Poster Area Randomized Clinical Trial (RCT) Representativeness & Outcomes in Relapsed/Refractory Multiple Myeloma (RRMM) Real World (RW) Patients: Comparison of ASPIRE, TOURMALINE-MM1, POLLUX & ELOQUENT RCTS. Abstract PS1336. Saturday, June 16, 5:30-7:00 p.m., Poster Area.

Pipeline

Phase 1/1b Study of Pevonedistat (PEV) as a Single Agent or Combined with Azacitidine (AZA) in East Asian Patients (Pts) with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS). Abstract PS997. Saturday, June 16, 5:30-7:00 p.m., Poster Area. TAK-659 Plus Bendamustine (+/-Rituximab), Gemcitabine, Lenalidomide or Ibrutinib in Patients (Pts) with Advanced Non-Hodgkin Lymphoma (NHL). Abstract PF281. Friday, June 15, 5:30-7:00 p.m., Poster Area.

For more information, please see ASCO ( https://am.asco.org/program ) and EHA ( http://eha-2018.org/ ) online programs.

About ADCETRIS ADCETRIS is an 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 regular approval for five indications in adult patients with: (1) previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy, (2) cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (3) 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, (4) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (5) 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 frontline Hodgkin lymphoma (ECHELON-1) and another Phase 3 study in frontline 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 Sézary 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) U.S. Important Safety Information

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:  Prolonged (≥1 week) severe neutropenia and Grade 3 or 4 thrombocytopenia or anemia can occur with ADCETRIS. Febrile neutropenia has been reported with ADCETRIS. Monitor complete blood counts prior to each ADCETRIS dose. Consider more frequent monitoring 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 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: Serious cases, including fatal outcomes, 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:  JC virus infection resulting in PML and death has 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:  Noninfectious pulmonary toxicity events including pneumonitis, interstitial lung disease, and acute respiratory distress syndrome, some with fatal outcomes, 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:  Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), including fatal outcomes, have been reported with ADCETRIS. If SJS or TEN occurs, discontinue ADCETRIS and administer appropriate medical therapy.

Gastrointestinal (GI) complications:  Acute pancreatitis, including fatal outcomes, has been reported in ADCETRIS-treated patients. Other fatal and serious GI complications, including perforation, hemorrhage, erosion, ulcer, intestinal obstruction, enterocolitis, neutropenic colitis, and ileus have been reported in ADCETRIS-treated patients. 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%) Adverse Reactions:  peripheral sensory neuropathy, fatigue, nausea, diarrhea, neutropenia, upper respiratory tract infection, and pyrexia.

Drug Interactions Concomitant use of strong CYP3A4 inhibitors or inducers, or P-gp inhibitors, 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, and for at least 6 months after the final dose of ADCETRIS treatment.

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 www.seattlegenetics.com or www.ADCETRIS.com .

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