Seattle Genetics (SGEN) Updates on Prescribing Info for ADCETRIS; Highlights PML Warning
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Seattle Genetics, Inc. (Nasdaq: SGEN) announced updates to the U.S. Prescribing Information (PI) for ADCETRIS (brentuximab vedotin). The revised PI will include the following updated information:
PML was described in the original PI for ADCETRIS based on a single case reported in a patient who had received four chemotherapy regimens prior to receiving ADCETRIS. Following the occurrence of a second case of PML, Seattle Genetics began working in conjunction with the FDA to add a boxed warning in order to heighten awareness of the potential risk of PML. There has also been a third suspected, but unconfirmed, case of PML reported in a heavily-pretreated patient receiving ADCETRIS.
In addition, based on data from a phase I clinical trial of ADCETRIS in combination with ABVD (Adriamycin, bleomycin, vinblastine and dacarbazine) for the treatment of newly diagnosed Hodgkin lymphoma patients, a contraindication for concomitant use of bleomycin and ADCETRIS will be added to the PI. This is based on data demonstrating that 40 percent of patients (10 out of 25) in the ADCETRIS plus ABVD cohorts of the trial had an event of pulmonary toxicity, compared to an overall rate of pulmonary toxicity with bleomycin-based regimens reported in published literature of 10 to 25 percent (2,3). To date, no pulmonary toxicity events have been observed in the ADCETRIS plus AVD cohorts of the trial. ADCETRIS is not approved for the front-line treatment of Hodgkin lymphoma.
- A boxed warning related to the risk that JC virus infection resulting in progressive multifocal leukoencephalopathy (PML) and death can occur in patients receiving ADCETRIS.
- A discussion in the PML warning and precaution provision regarding other possible contributing factors to PML such as other prior therapies and underlying disease, symptoms to be aware of and suggested methodologies for diagnosis of PML.
- A contraindication warning of the concomitant use of ADCETRIS and bleomycin due to pulmonary toxicity.
PML was described in the original PI for ADCETRIS based on a single case reported in a patient who had received four chemotherapy regimens prior to receiving ADCETRIS. Following the occurrence of a second case of PML, Seattle Genetics began working in conjunction with the FDA to add a boxed warning in order to heighten awareness of the potential risk of PML. There has also been a third suspected, but unconfirmed, case of PML reported in a heavily-pretreated patient receiving ADCETRIS.
In addition, based on data from a phase I clinical trial of ADCETRIS in combination with ABVD (Adriamycin, bleomycin, vinblastine and dacarbazine) for the treatment of newly diagnosed Hodgkin lymphoma patients, a contraindication for concomitant use of bleomycin and ADCETRIS will be added to the PI. This is based on data demonstrating that 40 percent of patients (10 out of 25) in the ADCETRIS plus ABVD cohorts of the trial had an event of pulmonary toxicity, compared to an overall rate of pulmonary toxicity with bleomycin-based regimens reported in published literature of 10 to 25 percent (2,3). To date, no pulmonary toxicity events have been observed in the ADCETRIS plus AVD cohorts of the trial. ADCETRIS is not approved for the front-line treatment of Hodgkin lymphoma.
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