Incyte Corp.’s retifanlimab-dlwr received its first regulatory nod on March 22, with the U.S. FDA granting accelerated approval for the PD-1 inhibitor to treat adults with a rare form of skin cancer, advanced Merkel cell carcinoma.
Concerns voiced during January’s U.S. FDA advisory committee meeting failed to deter Cidara Therapeutics Inc. from winning approval by the agency March 22 for once-weekly Rezzayo (rezafungin for injection) to treat a pair of indications – candidemia as well as invasive candidiasis (IC) – in adults with limited or no alternatives.
Despite a failed phase III study, the U.S. FDA suggests in briefing documents that tofersen (BIIB-067) is effective for treating the rare, genetic disease superoxide dismutase 1 amyotrophic lateral sclerosis (ALS). The intrathecally injected therapy is being developing by Biogen Inc. and Ionis Pharmaceuticals Inc. and is at the heart of a March 22 meeting of the agency’s Peripheral and Central Nervous System Drugs Advisory Committee (adcom).
Elekta AB received U.S. FDA clearance for what it called a “groundbreaking upgrade” of its MR-Linac platform which can continuously calculate the movement of a tumor anywhere in the body. The company said the Elekta Unity’s comprehensive motion management platform provides clinicians with enhanced, adaptive radiation therapy workflow to track moving organs such as the prostate, liver and pancreas.
The U.S. FDA has accepted Mesoblast Ltd.’s BLA resubmission for its allogeneic stem cell treatment remestemcel-L in children with steroid-refractory acute graft-vs.-host disease (SR-aGVHD). Mesoblast received a complete response letter from the FDA in October 2020 for remestemcel-L even though approval was highly anticipated after the FDA’s Oncologic Drugs Advisory Committee voted 9-1 that the stem cell therapy showed evidence of efficacy as a treatment for SR-aGVHD in children.
Acadia Pharmaceuticals Inc. will make available by the end of this month Daybue (trofinetide), a synthetic analogue of the amino‐terminal tripeptide of IGF-1 for Rett syndrome (RS), which was greenlighted by the U.S. FDA March 10 and remains in the works for fragile X syndrome as well as undisclosed other indications.
Pricing won’t be known until later for Pfizer Inc.’s Zavzpret (zavegepant), which became the first and only calcitonin gene-related peptide receptor antagonist nasal spray approved by the U.S. FDA for acute treatment of migraine with or without aura in adults. The product is slated to launch this summer. Meanwhile, Wall Street has questions about New York-based Pfizer’s performance in the migraine space.
Molecular Templates Inc. has received IND clearance from the FDA for its novel MT-8421 engineered toxin bodies (ETB) program targeting cytotoxic T-lymphocyte protein 4 (CTLA-4) in patients with relapsed/refractory solid tumors previously exposed to checkpoint inhibitors. MT-8421 is designed to eliminate CTLA-4-expressing regulatory T cells (Tregs) in the tumor microenvironment (TME) through a direct cell-kill mechanism independent of the effector cell presence that antibodies rely upon while not affecting Tregs in the periphery.
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