ImmunoGen’s Mirvetuximab Confidence Justified With Ovarian Cancer Win
Success Follows Accelerated Approval Setback In 2019
The response rate, with five complete responses, exceeds known responses to standard-of-care chemotherapy in heavily pre-treated folate receptor alpha-high patients. A US FDA filing is on track for early 2022.
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Public Company Edition: It has been almost a month since a biopharma firm launched an IPO in the US, but special purpose acquisition corporations continue to take drug makers public, including Alvotech and Aerami. Outside the US, MaaT closed an IPO in Paris and BeiGene priced a Shanghai offering.
The biotech’s hopes for an accelerated approval on subgroup data were dashed by the US FDA, but it will work with the agency to design a Phase III focused on highly FRα-positive patients.
Novartis got a leg up on its competition Aug. 30 with an earlier-than-expected approval for Kymriah in pediatric ALL, ending the CAR-T pricing mystery with its $475,000 price tag, which the company is positioning as a relative bargain.