Blockbuster BeiGene Cancer Drug Adds Another FDA Approval
The FDA approved BeiGene’s Brukinsa as a treatment for advanced cases of follicular lymphoma. It’s the fifth FDA nod for the drug, which has become BeiGene’s top-selling product.
The FDA approved BeiGene’s Brukinsa as a treatment for advanced cases of follicular lymphoma. It’s the fifth FDA nod for the drug, which has become BeiGene’s top-selling product.
Ipsen is paying $247 million to acquire Epizyme, a cancer drug developer with one FDA-approved product: follicular lymphoma therapy Tazverik. The drug is a modest seller now, but more cash could be paid out if the small molecule hits sales targets in coming years.
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Follicular lymphoma patients in Europe now have a new treatment option. The European Commission approved Roche drug Lunsumio, a bispecific antibody designed to go after two targets to treat advanced cases of this type of cancer.
FDA approval for Yescarta in follicular lymphoma makes it the first approved CAR-T treatment for this type of cancer. It also marks Gilead Sciences' third approved indication for a CAR-T cell therapy.
The company said Friday that it had submitted for approval of Yescarta in follicular and marginal zone lymphoma, based on data from the ZUMA-5 study that were presented at the 2020 ASCO meeting in May.
The company said the study of Kymriah in follicular lymphoma met its primary endpoint, though it did not disclose the trial data. It plans to submit approval applications to the FDA and EMA next year.
The company is seeking approval for Yescarta in follicular and marginal zone lymphomas. While it has a clear efficacy advantage over existing therapy options, experts said whether to use it in their place will entail complicated conversations with patients.
The company said the FDA had accepted its application for accelerated approval of Tazverik in relapsed/refractory follicular lymphoma. The drug won accelerated approval last month for epithelioid sarcoma.