Verastem Oncology

Tempus and Verastem Partner to Develop Companion Diagnostic for First FDA-Approved KRAS-Mutant LGSOC Treatment

3 days ago

• Tempus AI and Verastem Oncology have announced a collaboration to develop a companion diagnostic test for the recently FDA-approved combination therapy of avutometinib and defactinib for KRAS-mutated recurrent low-grade serous ovarian cancer. • The partnership builds on Tempus' confirmatory testing in Verastem's Phase 2 RAMP-201 clinical trial, with their FDA-approved xT CDx assay now being used as an investigational assay in the global Phase 3 RAMP-301 trial. • Low-grade serous ovarian cancer (LGSOC) is a rare form affecting younger women, accounting for 6-10% of serous ovarian cancers, with historically poor response to chemotherapy and limited treatment options.

FDA Approves Telix Pharmaceuticals' Novel Prostate Cancer Imaging Agent

2 months ago

• The U.S. Food and Drug Administration has granted approval for Telix Pharmaceuticals' new drug application for their prostate cancer imaging agent, offering improved diagnostic capabilities for clinicians. • This novel imaging technology enables more precise detection and localization of prostate cancer lesions, potentially leading to earlier intervention and improved patient outcomes. • The approval represents a significant advancement in prostate cancer management, addressing an important unmet need in the accurate visualization of cancer spread beyond the prostate gland.

Novel Drug Combination Overcomes Resistance in BRAF-Mutated Melanoma, Prevents Brain Metastasis

3 months ago

• Researchers have identified a promising combination therapy using FAK inhibitors with RAF-MEK clamps that effectively overcomes treatment resistance in BRAF V600E-mutated melanoma. • The dual-targeting approach not only treats existing brain metastases but also prevents melanoma cells from spreading to the brain, addressing a critical unmet need for patients with limited treatment options. • This oral combination therapy of defactinib (FAK inhibitor) and avutometinib (RAF-MEK inhibitor) could improve accessibility for melanoma patients in rural areas who struggle to access infusion-based immunotherapies.

Tempus AI Reports Strong Growth and Strategic Acquisition of Ambry Genetics in Q4 2024

3 months ago

• Tempus AI completed the acquisition of Ambry Genetics on February 3, 2025, positioning the company for significant expansion in precision medicine and AI-driven healthcare solutions. • The company launched its FDA-approved NGS-based diagnostic device, xT CDx, which received Advanced Diagnostic Laboratory Test status with a reimbursement rate of $4,500 per test. • Tempus projects approximately $1.24 billion in revenue for 2025, representing 79% annual growth, and expects to achieve $5 million in Adjusted EBITDA, a $110 million improvement over 2024.

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 Oncology Refinances Debt and Advances Avutometinib/Defactinib Combination

4 months ago

• Verastem Oncology secured a new credit facility of up to $150 million and a $7.5 million equity investment with Oberland Capital, refinancing existing debt with Oxford Finance. • A strategic collaboration with IQVIA aims to accelerate the commercial launch of the avutometinib and defactinib combination for recurrent KRAS mutant low-grade serous ovarian cancer (LGSOC). • The FDA granted priority review with a PDUFA date of June 30, 2025, for the NDA of avutometinib and defactinib in recurrent KRAS mutant LGSOC after prior systemic therapy. • Verastem exercised its option to license VS-7375, a KRAS G12D inhibitor, from GenFleet Therapeutics, with preliminary Phase 1 data from China showing promise.

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.

Verastem Oncology Gears Up for Potential 2025 Launch of Avutometinib Plus Defactinib in KRAS Mutant LGSOC

7 months ago

• Verastem Oncology anticipates a potential FDA decision on avutometinib plus defactinib for recurrent KRAS mutant low-grade serous ovarian cancer (LGSOC) by June 30, 2025. • The company plans for a mid-2025 U.S. commercial launch of the combination therapy in recurrent KRAS mutant LGSOC, pending FDA approval. • Clinical trials for avutometinib plus defactinib in metastatic pancreatic cancer and non-small cell lung cancer are progressing, with data updates expected in 2025. • Verastem is set to file an IND for VS-7375, a KRAS G12D inhibitor, in Q1 2025 and initiate a Phase 1/2a trial in the U.S. by mid-2025.

Cell Therapy and Targeted Therapies Dominate Oncology Advances in Early 2025

7 months ago

• The FDA issued a CRL for Atara Biotherapeutics' tabelecleucel due to third-party manufacturing issues, not efficacy or safety data, delaying potential approval for EBV+ PTLD. • EsoBiotec dosed the first patient in a trial for ESO-T01, an in vivo BCMA-directed CAR-T therapy for multiple myeloma, aiming for lower costs and simplified administration. • Obecabtagene autoleucel (obe-cel) gained FDA approval for relapsed/refractory B-cell precursor ALL, offering a less toxic CD19-directed CAR T-cell therapy option. • Arlocabtagene autoleucel (arlo-cel) shows promise in heavily pretreated relapsed/refractory multiple myeloma, eliciting a 48% complete response rate in phase 1 studies.

Verastem Oncology Completes FDA Submission for Avutometinib Plus Defactinib in Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer

7 months ago

• Verastem Oncology has completed its New Drug Application (NDA) submission to the FDA for avutometinib plus defactinib to treat recurrent KRAS mutant low-grade serous ovarian cancer (LGSOC). • The NDA is based on Phase 2 RAMP 201 trial data showing a 44% overall response rate and a median progression-free survival of 22 months in patients with KRAS mutant LGSOC. • The FDA previously granted Breakthrough Therapy Designation and Orphan Drug Designation to the combination therapy for LGSOC, and a decision is expected by mid-2025. • If approved, avutometinib plus defactinib would be the first FDA-approved treatment specifically for recurrent KRAS mutant LGSOC, addressing a significant unmet need.