Verastem | MedPath

Verastem Oncology to Present New LGSOC Treatment Data at SGO 2025 Annual Meeting

3 months ago

• Verastem Oncology will present additional analyses from the Phase 2 RAMP 201 trial evaluating avutometinib plus defactinib in recurrent low-grade serous ovarian cancer at SGO 2025, building on their FDA Priority Review submission. • The presentations include new subgroup analyses by KRAS mutational status, supporting the company's ongoing efforts to advance treatment options for RAS/MAPK pathway-driven cancers. • The company's NDA for the avutometinib-defactinib combination therapy has received Priority Review from the FDA with a PDUFA date of June 30, 2025, for KRAS mutant LGSOC patients.

Verastem's Avutometinib and Defactinib Combination Receives FDA Priority Review for Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer

5 months ago

• The FDA has granted Priority Review to Verastem Oncology's NDA for avutometinib combined with defactinib for recurrent KRAS mutant low-grade serous ovarian cancer (LGSOC). • The PDUFA target action date is set for June 30, 2025, with the FDA indicating that an advisory committee meeting is not currently planned. • The NDA is supported by Phase 2 RAMP 201 trial data, demonstrating substantial overall response rates and durable responses in patients with recurrent KRAS mutant LGSOC. • If approved, this combination therapy would be the first FDA-approved treatment specifically for adults with recurrent KRAS mutant LGSOC, addressing a significant unmet need.

Applied Therapeutics Announces Leadership Changes and Strategic Updates

5 months ago

• Applied Therapeutics appoints John H. Johnson as Executive Chairman, leveraging his extensive experience to drive growth and value creation. • Les Funtleyder steps in as Interim CEO while maintaining his role as CFO, ensuring continuity and focus on pipeline advancement. • The company is re-evaluating its regulatory strategy for govorestat, including NDA submission for SORD Deficiency after Q1 2025. • Applied Therapeutics is withdrawing its MAA application in Europe for govorestat in Classic Galactosemia, pending further data acquisition.

Verastem's Avutometinib and Defactinib Combination Therapy Shows Promise in LGSOC and Other Cancers

9 months ago

• Verastem is advancing Avutometinib and Defactinib combination therapy for recurrent Low-Grade Serous Ovarian Cancer (LGSOC), with a rolling NDA submission expected to be finalized in 2H2024. • The combination therapy targets the RAS/MAPK pathway and inhibits focal adhesion kinase, offering a dual approach to disrupt cancer cell growth and metastasis. • Clinical trials show promising overall response rates, particularly in KRAS-mutated patients, suggesting a potential breakthrough in treating this resistant condition. • Verastem is also exploring the combination therapy's efficacy in metastatic pancreatic cancer and KRAS G12C mutant non-small cell lung cancer, expanding its oncology applications.