FDA Approves Braftovi/Mektovi for Non-Small Cell Lung Cancer

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The two-drug regimen of Braftovi and Mektovi was approved to treat patients who have a subset of non-small cell lung cancer, those with a BRAF V600E mutation.

The FDA has approved Pfizer’s combination of Braftovi (encorafenib) + Mektovi (binimetinib) to treat adult patients with metastatic non-small cell lung cancer (NSCLC) with a BRAF V600E mutation.

BRAF V600E mutations are subtype of metastatic non-small cell lung cancer, accounting about 2% of all non-small cell lung cancer cases. Lung cancer is the second most common type of cancer and the number one cause of cancer-related death around the world. Non-small cell lung cancer accounts for about 80% to 85% of all lung cancers.

Braftovi and Mektovi are both kinase inhibitors and target specific proteins kinase that are altered in cancer cells, which impacts cell survival. The combination of the two drugs targets two different kinases. Braftovi addresses BRAF V600E, as well as wild-type BRAF and CRAF; Mektovi targets MEK1 and MEK2 downstream of BRAF.

Braftovi and Mektovi is also approved to treat patients with unresectable or metastatic melanoma with a BRAF V600E or V600K mutation. Additionally, Braftovi is also approved in combination with cetuximab, to treat adult patients with metastatic colorectal cancer.

Braftovi has a price of about $13,373.72 for a month’s supply, and Mektovi has a price of $13,121.37 for a month’s supply. Pfizer offers patients a $0 copay assistance for up to $25,000 a year annually, as well as patient assistance program for those without insurance.

The approval is based on data from the ongoing phase 2 PHAROS clinical trial, an open-label, study examining Braftovi and Mektovi in both treatment-naïve and previously treated patients with BRAF V600E-mutant metastatic NSCLC.

Gregory Riely, M.D., Ph.D.

Gregory Riely, M.D., Ph.D.

“The PHAROS trial demonstrated that these patients could benefit from Braftovi + Mektovi targeted therapy regardless of their prior treatment history. Given the specific efficacy and safety profile, patients and providers now have another option to help personalize treatment plans based on individual risk factors and preferences,” Gregory Riely, M.D., Ph.D., vice chair, Clinical Research in the Department of Medicine at Memorial Sloan Kettering Cancer Center (MSK) and PHAROS investigator, said in a press release.

The PHAROS study met its major efficacy outcome measures of objective response rate, as and duration of response in both treatment groups. For the 59 treatment-naïve patients, objective response rate was 75%, and 59% of the patients responded for at least 12 months. Median duration of response was not estimable at the time of data cutoff. For the 39 previously treated patients, objective response rate was 46%, and 33% of the patients responded for at least 12 months. Median duration of response was 16.7 months.

Serious adverse reactions occurred in 38% of patients and included hemorrhage, diarrhea, anemia, dyspnea, pneumonia, arrhythmia, device-related infection, edema, myocardial infarction, and pleural effusion. Fatal adverse reactions occurred in 2% of patients, including intracranial hemorrhage and myocardial infarction.

These data were presented earlier this year at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting and published in the Journal of Clinical Oncology.

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