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Novocure's Device Shows Promise in Pancreatic Cancer, FDA Reviews Cytokinetics' Heart Drug

• Novocure's electrical field-emitting device, combined with chemotherapy, significantly extended survival in locally advanced pancreatic cancer patients by two months in a Phase 3 trial. • The FDA is set to decide on Cytokinetics' aficamten for obstructive hypertrophic cardiomyopathy by September 26, 2025, following positive Phase 3 trial results. • Merus has granted Partner Therapeutics U.S. rights to zenocutuzumab, an experimental cancer drug currently under FDA review for NRG1 fusion-positive tumors, with a decision expected by February 4, 2025. • The FDA is investigating blood cancer cases linked to Bluebird bio's gene therapy Skysona, advising caution and consideration of alternative treatments like stem cell transplants.

Novocure announced positive topline results from its Phase 3 PANOVA-3 clinical trial, revealing that its tumor-treating fields (TTFields) therapy, in conjunction with chemotherapy, significantly improved overall survival in patients with locally advanced pancreatic cancer. Participants treated with the device plus chemotherapy survived for an average of just over 16 months, a statistically significant two-month increase compared to chemotherapy alone.

Novocure's TTFields Therapy in Pancreatic Cancer

The trial's findings mark a significant step forward in treating this aggressive cancer. Novocure intends to seek regulatory approval for this indication, building on the device's existing clearances for glioblastoma, mesothelioma, and non-small cell lung cancer. The company's device delivers low-intensity, alternating electrical fields to disrupt cancer cell division.

Cytokinetics' Aficamten Awaits FDA Decision

The FDA has accepted Cytokinetics’ application for aficamten, a heart drug aimed at treating obstructive hypertrophic cardiomyopathy. The decision date is set for September 26, 2025. This application is supported by Phase 3 trial data demonstrating improved exercise capacity in patients with the condition. If approved, aficamten will enter a market already served by Bristol Myers Squibb’s Camzyos.

Merus Licenses Zenocutuzumab to Partner Therapeutics

Merus has licensed the U.S. rights to its investigational cancer drug, zenocutuzumab, to Partner Therapeutics. Zenocutuzumab, an antibody, is currently under FDA review for treating NRG1 fusion-positive tumors. The FDA extended its review period, with a decision now expected by February 4, 2025.

FDA Investigates Bluebird Bio's Skysona

The FDA is formally investigating cases of blood cancer following treatment with Bluebird bio’s gene therapy Skysona. The agency's notice references previously reported cases, raising concerns about the therapy's safety profile. The FDA recommends that healthcare providers carefully consider alternative treatments, such as hematopoietic stem cell transplants, for patients with matched donors due to the potential risk of blood cancer.
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Reference News

[1]
Novocure device succeeds in pancreatic cancer study; FDA sets Cytokinetics decision date
biopharmadive.com · Dec 2, 2024

Novocure's electrical field-emitting device in Phase 3 trial showed extended survival in pancreatic cancer patients when...

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