Seattle Genetics: Advancing Antibody-Drug Conjugates for …

Full Prescribing Information

Indications and Important Safety Information, Including Boxed Warning

ADCETRIS Indications ADCETRIS (brentuximab vedotin) Injection for intravenous infusion has been granted accelerated approval by the U.S. Food & Drug Administration for two indications:

These indications are approved under accelerated approval based on overall response rate. An improvement in patient-reported outcomes or survival has not been established. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

BOXED WARNING Progressive multifocal leukoencephalopathy (PML): JC virus infection resulting in PML and death can occur in patients receiving ADCETRIS.

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

Warnings and Precautions

Adverse Reactions ADCETRIS was studied as monotherapy in 160 patients in two phase 2 trials. Across both trials, the most common adverse reactions (20%), regardless of causality, were neutropenia, peripheral sensory neuropathy, fatigue, nausea, anemia, upper respiratory tract infection, diarrhea, pyrexia, rash, thrombocytopenia, cough and vomiting.

Drug Interactions Concomitant use of strong CYP3A4 inhibitors or inducers, or P-gp inhibitors, has the potential to affect the exposure to monomethyl auristatin (MMAE).

Use in Specific Populations MMAE exposure and adverse reactions are increased in patients with moderate or severe hepatic impairment or severe renal impairment. Avoid use.

Full Prescribing Information, including Boxed WARNING - U.S.

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Seattle Genetics: Advancing Antibody-Drug Conjugates for ...