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Orserdu, a drug from Menarini Group subsidiary Stemline Therapeutics, is now approved for treating breast cancers that carry the ESR1 mutation. The drug is the first approved oral therapy from a class of therapies called selective estrogen receptor degraders (SERDS).
The first BTK inhibitor of any kind approved for mantle cell lymphoma treated with a covalent BTK inhibitor, has been granted FDA approval.
The FDA has granted accelerated approval to Jaypirca™ (pirtobrutinib) for relapsed or refractory mantle cell lymphoma.
The FDA granted accelerated approval to pirtobrutinib for treatment of certain patients with advanced mantle cell lymphoma.The indication applies to use of the agent by adults with relapsed or refractory disease who received at least two lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor.
This drug is the first BTK inhibitor approved to treat mantle cell lymphoma in this setting. Approval was based on overall response rates and duration of response in the phase 1/2 BRUIN trial.