Sponsors developing PI3K inhibitors to treat hematologic malignancies in the U.S. may have to up their game if they want to get FDA approval. The Oncologic Drugs Advisory Committee voted 16-0, with one abstention, that future approvals of the drugs should be supported by randomized data. Given the FDA’s briefing document ahead of the April 21 meeting and its presentations to the committee, the agency is likely to follow that recommendation.
Genequantum Healthcare Co. Ltd. will work with Aimedbio Inc. to co-develop an antibody-drug conjugate (ADC) to treat brain and other cancers, working toward an IND filing in 2023.
With renewed focus on the U.S. Cancer Moonshot, the price of oncology drugs is more than a satellite issue, especially as new drugs launch with ever-increasing prices and other cancer drugs continue to see price hikes.
Just two weeks after winning U.S. FDA approval for the first orally dissolving formulation of dexmedetomidine for agitation in schizophrenia and bipolar disorders, Bioxcel Therapeutics Inc. has secured commitments for up to $260 million to support the product’s commercial launch, slated for this quarter in addition to a planned European marketing application.
Regeneron Pharmaceuticals Inc. proposes to buy Checkmate Pharmaceuticals Inc. though an all-cash price of $10.50 per share for about $250 million. That’s pretty much on target with Checkmate’s April 19 closing share price (NASDAQ:CMPI) of $10.35, as the stock gained a staggering 326% on the day.
A week before the U.S. FDA’s Oncologic Drugs Advisory Committee was to meet and review TG Therapeutics Inc.’s BLA and sNDA for the combo of ublituximab and Ukoniq (umbralisib) for treating chronic lymphocytic leukemia and small lymphocytic lymphoma, the company voluntarily withdrew the submission and now is rethinking its oncology programs. The move was tied to an FDA-requested analysis of phase III data showing that, while study met its primary endpoint, there was an imbalance in updated overall survival (OS) results favoring the control arm. A June 25 PDUFA date had been set for the combination treatment.
As Wall Street awaits data from VBL Therapeutics Inc.’s phase III trial with ofranergene obadenovec (ofra-vec, also known as VB-111) in platinum-resistant ovarian cancer (PROC), the company hosted a key opinion leader conference call on the gene therapy’s likely market reception along with assorted details regarding the upcoming results from the 409-patient experiment known as Oval.
New and updated preclinical and clinical data presented by biopharma firms at the American Association for Cancer Research annual meeting, including: Akeso, Ascentage, Celsion, Foghorn, Onconano.
Results from a phase III study comparing Celltrion Inc.’s biosimilar VEGF ligand inhibitor CT-P16 to Roche Holding AG’s Avastin (bevacizumab) in patients with metastatic or recurrent non-squamous non-small-cell lung cancer (NSCLC) found it to be similarly effective and as safe compared to the reference drug. Incheon, South Korea-based Celltrion presented the results at the 2022 annual meeting of the American Association for Cancer Research. The company now plans “to speed up the approval process through consultation with regulatory authorities in each country,” a Celltrion official said.
New and updated preclinical and clinical data presented by biopharma firms at the American Association for Cancer Research annual meeting, including: Alpine, Apexigen, Basilea, Biopath, CG, Chemocentryx, Cstone, Deciphera, Erasca, Gritstone, Highlight, Kineta, Mustang, Neoimmunetech, Neoleukin, Oric, Portage, Sotio, Trishula.
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