The regulator Wednesday approved expanding Lonsurf’s label for previously treated metastatic colorectal cancer, authorizing a combination regimen with Roche’s bevacizumab.
Amid the impending drug pricing pressures from the Inflation Reduction Act, Roche is discontinuing a mid-stage hemophilia A gene therapy candidate and four other early-stage hopefuls.
Under the deal, Roche will make an upfront payment of $310 million in cash. Alnylam is also entitled to development, regulatory and sales milestones, with a potential contract value of up to $2.8 billion.
The sale of the drug could be announced in the coming days, the report said, citing people familiar with the matter. The talks could still fall apart and another suitor could swoop in, it added.
Data from the OCARINA II trial shows that a 10-minute subcutaneous injection of Ocrevus achieves similar pharmacokinetics as the typical hours-long intravenous infusion in multiple sclerosis patients.
Phase III trial data published Thursday show significant survival benefit as a first-line treatment in advanced non-small cell lung cancer patients not fit for standard platinum-based doublet chemotherapy.
The response rate exceeded the prespecified efficacy threshold and suggests epcoritamab may hold its own against Roche’s rival CD3xCD20 bispecific Lunsumio, which won FDA approval in follicular lymphoma last year.
The U.S. Food and Drug Administration (FDA) greenlighted Roche Holding AG’s experimental therapy to treat a type of advanced blood cancer, nearly a month after the approval of a rival therapy from AbbVie Inc.
Swiss drugmaker Roche Holding AG plans to sell its 800-employee drug manufacturing plant in Vacaville, California, or it will shut the factory by 2029, according to e-mailed letters to workers seen by Reuters on Wednesday.
With Friday’s approval, Epkinly edges out Roche’s bi-specific antibody glofitamab, which is also being proposed for diffuse large B-cell lymphoma.