Onco360 Has Been Selected as a National Specialty Pharmacy Partner for AVMAPKI™FAKZYNJA™ CO-PACK
LOUISVILLE, Ky., May 12, 2025 (GLOBE NEWSWIRE) -- Onco360®, the nation’s leading independent specialty pharmacy, has been selected as a national pharmacy partner by Verastem Oncology for AVMAPKI™ FAKZYNJA™ CO-PACK (avutometinib capsules; defactinib tablets), for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy.1 This indication was approved on March 8th, 2025 based on the Phase 2 RAMP-201 study in adults (≥18 years of age) with low grade serous ovarian cancer.2
“Onco360 is excited for the opportunity to partner with Verastem Oncology and become a specialty pharmacy provider for AVMAPKI™ FAKZYNJA™ CO-PACK,” said Benito Fernandez, Chief Commercial Officer at Onco360. “We are proud to add AVMAPKI™ FAKZYNJA™ CO-PACK, for the treatment of KRAS-mutated recurrent low-grade serous ovarian cancer patients to our portfolio.”
Avutometinib potently inhibits MEK1/2 kinase activities and induces inactive complexes of MEK with ARAF, BRAF, and CRAF, potentially creating a more complete and durable anti-tumor response through maximal RAS/MAPK pathway inhibition. Defactinib is an oral, selective inhibitor of focal adhesion kinase (FAK) and proline-rich tyrosine kinase-2 (Pyk2), the two members of the focal adhesion kinase family of non-receptor protein tyrosine kinases. FAK and Pyk2 integrate signals from integrin and growth factor receptors to regulate cell proliferation, survival, migration, and invasion. FAK activation has been shown to mediate resistance to multiple anti-cancer agents, including RAF and MEK inhibitors.
The FDA approved AVMAPKI™ FAKZYNJA™ CO-PACK based on the results of the RAMP-201 study, a multicenter randomized, open-label trial, that evaluated the safety and efficacy of avutometinib given alone and in combination with defactinib for the treatment of patients with histologically confirmed recurrent low-grade serous ovarian or peritoneal cancer.2 During the study, 57 patients with KRAS-mutated LGSOC received AVMAPKI™ 3.2mg orally twice weekly and FAKZYNJA™ 200mg orally twice daily for the first 3 weeks in a 4 week cycle until disease progression or unacceptable toxicity.
With this combination, the confirmed ORR was 44% (95% CI, 31%-58%) for those harboring KRAS mutations (n = 57).
The safety data for the RAMP-201 trial showed the most common (≥25%) adverse reactions, including laboratory abnormalities, increased creatine phosphokinase, nausea, fatigue, increased aspartate aminotransferase, rash, diarrhea, musculoskeletal pain, edema, decreased hemoglobin, increased alanine aminotransferase, vomiting, increased blood bilirubin, increased triglycerides, decreased lymphocyte count, abdominal pain, dyspepsia, dermatitis acneiform, vitreoretinal disorders, increased alkaline phosphatase, stomatitis, pruritus, visual impairment, decreased platelet count, constipation, dry skin, dyspnea, cough, urinary tract infection, and decreased neutrophil count.1
Please see the full Prescribing Information for AVMAPKI™ FAKZYNJA™ CO-PACK.
About Onco360 Oncology Pharmacy:
Onco360 is the nation’s largest independent Oncology Pharmacy and clinical support services company. Onco360 was founded in 2003 to bring together the stakeholders involved in the cancer treatment process and serve the specialized needs of oncologists, patients, hospitals, cancer centers of excellence, manufacturers, health plans, and payers. It dispenses nationally through its network of URAC-, and ACHC-accredited Oncology Pharmacies. Onco360 is headquartered in Louisville, Kentucky, and is a flagship specialty pharmacy brand of PharMerica Corporation, a leading institutional pharmacy, specialty infusion, and hospital services company servicing healthcare facilities in the United States. For more information about Onco360, please visit Onco360.com.
Media Contact: Benito Fernandez, Chief Commercial Officer
Benito.Fernandez@Onco360.com
516-640-1332
References:
1AVMAPKI™ FAKZYNJA™ CO-PACK (avutometinib capsules; defactinib tablets), [Package Insert]. Needham, MA. Verastem Oncology. 2025.
2Banerjee, SN, et al. Initial efficacy and safety results from ENGOT-ov60/GOG-3052/RAMP 201: A phase 2 study of avutometinib (VS-6766) ± defactinib in recurrent low-grade serous ovarian cancer (LGSOC). JCO 41, 5515-5515(2023).