Pfizer and Arvinas' Veppanu Gets FDA OK Alongside Guardant Health CDx for ESR1-Mutated Breast Cancer
The agency's decision was based on data from the VERITAC-2 trial, which showed Veppanu improved progression-free survival by nearly three months over fulvestrant.
The US Food and Drug Administration gave the company the green light to begin the program for patients with previously treated metastatic pancreatic cancer.
The firm, having run into roadblocks trying to bring AMT-130 to market in the US, said it is "actively pursuing" regulatory approvals internationally.
The ODAC voted seven to one that data from the CAPItello-281 trial showed a favorable benefit-risk profile for Truqap plus abiraterone and ADT.
The firm said that after reviewing its oncology portfolio and seeing the PRMT5 inhibitor's initial activity, it decided to discontinue its development.
The firm posted $19.8 billion in total quarterly revenue, primarily driven by GLP-1 drugs but with contributions from ...
The firm reported an 8 percent increase in sales in the first quarter for its Keytruda family of products, which includes both Keytruda and the subcutaneous Keytruda Qlex.
The panel voted six to three that the available evidence doesn't support switching patients to AstraZeneca's camizestrant based on ESR1 mutations detected in circulating tumor DNA.
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