The FDA has alerted healthcare providers and patients about an increased risk of new blood cancers tied to Tazverik (tazemetostat) and said the drug’s sponsor plans to withdraw the product from the U.S. market. Tazverik was approved under the FDA’s…
Pharmacy
The FDA has approved Bizengri for adults with advanced, unresectable or metastatic cholangiocarcinoma harboring a neuregulin 1 gene fusion whose disease progressed on or after prior systemic therapy. Bizengri is the first approved treatment for patients with NRG1 fusion-positive cholangiocarcinoma,…
The FDA has approved Filkri (filgrastim-laha), a biosimilar to Neupogen (filgrastim), for use in cancer patients at risk of infection due to chemotherapy. Filkri is indicated for patients receiving myelosuppressive chemotherapy, those with acute myeloid leukemia undergoing induction or consolidation…
At Morgantown, W.Va.-based WVU Medicine, one of the biggest shifts in cancer care is not happening inside a hospital. It is happening closer to patients’ homes. Over the past several years, the health system has expanded oncology and infusion services…
The FDA has granted priority review to the supplemental biologics license application for Datroway (datopotamab deruxtecan) in adults with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy. The application is supported by results from…
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As cancer care becomes increasingly driven by complex, high-cost therapies, health systems are rethinking how tightly oncology and pharmacy are integrated. At Mount Sinai Medical Center in Miami Beach, Fla., leadership sees pharmacy not as a downstream support function but…
Bishop, Calif.-based Northern Inyo Healthcare District held a ribbon-cutting ceremony Jan. 22 to celebrate the opening of its new pharmacy and updated infusion center, according to a Jan. 22 report by Sierra Wave Media. The health system said the event…
The FDA issued draft guidance Jan. 21 proposing the use of minimal residual disease and complete response as primary endpoints to support accelerated approval of drugs for multiple myeloma. The draft guidance outlines recommendations for trial design, statistical methods and…
At many health systems, infusion services operate across multiple sites with varying workflows and approval processes. At Cone Health, based in Greensboro, N.C., pharmacy leaders have spent the past year aligning those services — particularly outside of oncology — as…
Atara Biotherapeutics received a second complete response letter from the FDA for its biologics license application for Ebvallo (tabelecleucel). The letter, received Jan. 9, said the FDA no longer considers the single-arm ALLELE trial adequate to support accelerated approval for…