Latest news with #AvmapkiFakzynja
Epoch Times
09-05-2025
- Health
- Epoch Times
FDA Approves Verastem's Ovarian Cancer Therapy for Some Adult Patients
The Food and Drug Administration (FDA) has granted accelerated approval to biopharmaceutical company Verastem Oncology's combination therapy for adults who have received prior treatment for a rare type of ovarian cancer, the regulator announced on Thursday. The FDA It marks the first and only approval for a drug to treat adults with this form of cancer, the Massachusetts-based drug maker said. The new therapy will be available in the United States in one week at a list price of LGSOC is a rare ovarian cancer that is both insidious and persistent, Approximately 6,000–8,000 women in the United States and 80,000 worldwide are living with this disease, which is typically diagnosed in those in the age ranges of 20–30 and 50–60 and has a median survival of approximately 10 years, according to Verastem. Related Stories 5/9/2025 5/8/2025 Dan Paterson, president and chief executive officer of Verastem Oncology, said the approval represents 'not only the first-ever FDA-approved treatment specifically for this rare cancer but also a new day for people living with this disease who have been in desperate need of new treatment options.' 'We are very proud to bring two innovative medicines in one combination treatment to the LGSOC community,' Paterson said. 'We thank the researchers, patients, and their families participating in our clinical trials, the patient advocacy community, the FDA, and everyone at Verastem for their dedication and commitment to helping us bring AVMAPKI FAKZYNJA CO-PACK to patients in the U.S.' Approval of Avmapki Fakzynja was based on data from a mid-stage trial of 57 patients with KRAS-mutated recurrent LGSOC who were treated with at least one prior therapy, including a platinum-based regimen, the FDA said. Patients received 3.2 mg of Avmapki orally twice weekly for three weeks and 200 mg of Fakzynja orally twice daily for three weeks until disease progression or unacceptable toxicity. In the trial, Verastem's drug demonstrated a 44 percent overall response rate and was generally well tolerated, the FDA stated. The most common adverse reactions included nausea, fatigue, rash, diarrhea, musculoskeletal pain, edema, decreased hemoglobin, vomiting, abdominal pain, decreased platelet count, constipation, dry skin, and urinary tract infection, among others, according to the FDA. Verastem said possible serious side effects also include ocular disorders, skin toxicities, hepatotoxicity, rhabdomyolysis, and fetal harm when administered during pregnancy. The combination drug works by inhibiting multiple pathways that promote cancer cell survival and growth and drug resistance. Shares of Verastem Oncology climbed 5 percent in afternoon trading and are currently trading at $6.94.
Reuters
08-05-2025
- Health
- Reuters
US FDA approves Verastem's ovarian cancer therapy
May 8 (Reuters) - The U.S. Food and Drug Administration has approved Verastem's (VSTM.O), opens new tab combination therapy for patients with a rare type of ovarian cancer who have received prior treatment, the regulator said on Thursday. The combination drug, branded as Avmapki Fakzynja Co-pack, will be available in one week, the company said. Pricing details for it were not available. The FDA decision marks the first and only approval for a drug to treat adults with this form of cancer, called low-grade serous ovarian cancer with a mutation in a gene known as KRAS. About 6,000-8,000 women in the U.S. and 80,000 worldwide are living with this disease, according to the company. The cancer disproportionately affects younger women and has poor response rates to chemotherapy. Approval for the drug was based on data from a mid-stage trial of 57 patients who were treated with at least one prior therapy. In the trial, Verastem's drug significantly improved patients' response rate while being generally well tolerated. Share of the company were halted in mid-day trading.
