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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ImmunoGen may need to mount an aggressive education campaign to get in front of issues like blurred vision and keratopathy, with ocular toxicity being common among antibody-drug conjugates.
Keeping Track: Novel Oncologics Submitted By Taiho, ImmunoGen, Y-mAbs; US FDA Declines Akebia’s Vadadustat
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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.