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 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 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, having run into roadblocks trying to bring AMT-130 to market in the US, said it is "actively pursuing" regulatory approvals internationally.
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.
Kestrel has dosed the first patient in its Phase I trial evaluating KST-6051 in patients with advanced or metastatic solid tumors with KRAS mutations.
NEW YORK - The National MPS Society this week said it is awarding a $4 million grant to support a gene therapy program for mucopolysaccharidoses (MPS) IIIB (Sanfilippo syndrome type B) led by ...
NEW YORK – The majority of experts on a US Food and Drug Administration advisory panel on Thursday remained unconvinced that there's sufficient evidence to support giving certain advanced breast ...