Merck's (MRK) Lung Cancer Candidate Faces FDA Rejection [Yahoo! Finance]
Merck & Company, Inc. (new) (MRK)
Last merck & company, inc. (new) earnings: 4/28 06:45 am
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Source: Yahoo! Finance
application (BLA) seeking accelerated approval for patritumab deruxtecan for previously-treated EGFR-mutated non-small cell lung cancer (NSCLC). The BLA seeks approval for patritumab deruxtecan, a specifically engineered potential first-in-class HER3-directed DXd antibody drug conjugate (ADC), to treat adult patients with locally advanced or metastatic EGFR-mutated NSCLC previously treated with two or more systemic therapies. The FDA's CRL was based on observations made after the inspection of a third-party manufacturing facility. The FDA has not requested any additional efficacy/safety studies, nor has it identified any issues related to the safety and efficacy of the candidate. Merck said it will work closely with the FDA and the third-party manufacturer to resolve the issue. The BLA was supported by data from the HERTHENA-Lung01 pivotal phase II study. The study demonstrated an objective response rate of 29.8%, while the median duration of response (DoR) was 6.4 months. Mer
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MRK
Earnings
- 4/25/24 - Beat
MRK
Sec Filings
- 6/25/24 - Form 11-K
- 6/25/24 - Form 11-K
- 6/25/24 - Form 11-K
- MRK's page on the SEC website