Pfizer announces FDA approval for Braftovi/Mektovi combination in lung cancer
上市批准临床研究引进/卖出临床结果
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来源: PMLiVE
Pfizer has announced that a new personalised treatment option, Braftovi (encorafenib) plus Mektovi (binimetinib), has been approved by the US Food and Drug Administration (FDA) for certain lung cancer patients.
The regulator’s decision specifically applies to adults with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as detected by an FDA-approved test.
Lung cancer is the second most common type of cancer and NSCLC accounts for up to 85% of all lung cancers cases.
Certain lung cancers are linked to acquired genetic abnormalities such as a BRAF V600E mutation, which occurs in approximately 2% of NSCLC cases.
"BRAF V600E mutations identify a unique subtype of metastatic NSCLC that presents an actionable biomarker that precision medicines like Braftovi plus Mektovi combination therapy can help address,” explained Gregory Riely, an investigator in the ongoing mid-stage PHAROS trial that supported the FDA’s approval.
The study, which is evaluating the combination therapy in both treatment-naïve and previously treated patients with BRAF V600E-mutant metastatic NSCLCBRAF V600E-mutant metastatic NSCLC, met its major efficacy outcome measures of objective response rate and duration of response in both treatment groups.
“The PHAROS trial demonstrated that these patients could benefit from Braftovi plus Mektovi targeted therapy regardless of their prior treatment history," Riely said. "Given the specific efficacy and safety profile, patients and providers now have another option to help personalise treatment plans based on individual risk factors and preferences.”
The Braftovi/Mektovi combination is also approved by the FDA to treat patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation, and Braftovi is approved in combination with cetuximab to treat adults with metastatic colorectal cancer with a BRAF V600E mutation.
Chris Boshoff, chief oncology research and development officer and executive vice president at Pfizer, said: “Since its initial FDA approval in 2018, Braftovi plus Mektovi combination therapy has helped thousands of people living with BRAF V600E- or V600K-mutant unresectable or metastatic melanomaBRAF V600E- or V600K-mutant unresectable or metastatic melanoma.
Pfizer has exclusive rights to Braftovi and Mektovi in the US, Canada and all countries in Latin America, Africa and the Middle East, while Ono Pharmaceutical has exclusive rights for both products in Japan and South Korea, Medison has exclusive rights in Israel, and Pierre Fabre has exclusive rights in all other countries.
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