- After an increased number of adverse events, Gilead will halt six clinical trials involving its cancer med Zydelig in combination with other cancer drugs, the FDA confirmed in a safety alert.
- The move comes several days after the European Medicines Agency began a review to investigate higher rates of adverse reactions, including deaths related to infection, in three clinical trials combining Zydelig with other drugs.
- Zydelig is currently indicated in the U.S. as a monotherapy for third-line treatment of follicular lymphoma and small lymphocytic lymphoma. It also is approved as part of combo therapy with Roche's Rituxan (rituximab) for treatment of chronic lymphocytic leukemia (CLL).
Known principally for its HIV and liver drugs, Zydelig is represents Gilead's first commercial foray into oncology. The company is currently working on expanding its indication, particularly in combination with other drugs. Sales in 2015 were $132 million, small change for a company which raked in over $30 billion globally for its antiviral treatments.
The combo trials were investigating Zydelig in patients with CLL, small lymphocytic lymphoma, and indolent non-Hodgkin lymphoma. However, the FDA cautioned healthcare providers that Zydelig is not currently approved to treat patients with CLL who haven't previously received other treatments.
Like the EMA, the FDA will review data from the clinical trial to determine if additional actions are necessary. Zydelig was approved in the U.S. in July 2014, and subsequently approved in the E.U. that following September.