Today, a brief rundown of news involving Novocure and Merus, as well as updates from Cytokinetics, Fate Therapeutics and Bluebird bio that you may have missed.
Novocure said its electrical field-emitting device alongside chemotherapy helped people with locally advanced pancreatic cancer live longer than those who received only chemo in a Phase 3 trial. Trial participants treated with Novocure’s therapy survived for an average of just over 16 months, a statistically significant, two-month difference versus chemo alone, the company said. Novocure intends to file for regulatory approval in pancreatic cancer. The device is already cleared to treat glioblastoma, mesothelioma and non-small cell lung cancer. — Jonathan Gardner
Merus has licensed to Partner Therapeutics U.S. rights to its experimental cancer drug zenocutuzumab for an undisclosed sum, the companies announced Monday. An antibody drug, zenocutuzumab is under Food and Drug Administration review for use treating NRG1 fusion-positive tumors. The agency recently extended its evaluation and now expects to reach a decision on approval by Feb. 4, 2025. — Ned Pagliarulo
The Food and Drug Administration will decide by Sept. 26, 2025, whether to approve Cytokinetics’ heart drug aficamten in obstructive hypertrophic cardiomyopathy, the company said Monday. The agency accepted Cytokinetics’ application, which was based on the results of a Phase 3 trial showing use of aficamten improved exercise capacity for people with the condition. If approved, aficamten will compete with Bristol Myers Squibb’s Camzyos, approved in 2022. The announcement follows moves by Cytokinetics to sell partial rights to the drug, including a royalty deal with Royalty Pharma and a Japanese licensing deal with Bayer. Cytokinetics previously had another heart failure drug rejected by the FDA. — Jonathan Gardner
The FDA is now formally investigating cases of blood cancer following treatment with Bluebird bio’s gene therapy Skysona. The Nov. 27 notice from the agency cites cases Bluebird previously reported, details of which were published in October in The New England Journal of Medicine. No new cases or safety information preceded the FDA’s announcement, a Bluebird spokesperson confirmed to BioPharma Dive. However, the agency did recommend that providers “carefully consider” alternative therapies like a hematopoietic stem cell transplant for prospective patients who have a matched donor, due to the blood cancer risk. — Ned Pagliarulo
Fate Therapeutics president and CEO Scott Wolchko will retire at the end of the year, ending a nearly decade-long stint running the “natural killer” cell therapy developer. The company said on Nov. 29 that longtime research chief Bob Valamehr will take over as its head at the start of 2025, with Wolchko transitioning to a “strategic adviser.” Fate previously only developed cancer therapies. But the company reset in 2023 and, like many of its peers, has made autoimmune disease research a focus as well. One program is now in early-stage testing in lupus. — Ben Fidler
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- Source: https://www.biopharmadive.com/news/novocure-cytokinetics-merus-partner-therapeutics-deal-bluebird/734246/