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FDA nod for Pfizer’s combination therapy for non-small cell cancer

The Food and Drug Administration has approved Pfizer Inc.’s treatment for metastatic non-small cell lung cancer.

HQ Team

October 12, 2023: The Food and Drug Administration has approved Pfizer Inc.’s treatment for metastatic non-small cell lung cancer.

The FDA gave the green light for a combination therapy of Braftovi and Mektovi drugs based on data from the ongoing phase 2 clinical trial of the company, according to a Pfizer statement.

“By pursuing precision medicines that target a patient’s specific type of cancer, we are leveraging our deep understanding of tumour biology to help address the underlying cause of disease,” said Chris Boshoff, MD, PhD, Executive Vice President at Pfizer.

The trial met its major efficacy outcome measures of objective response rate as assessed by the independent review committee, and duration of response in both treatment groups, according to the statement. 

Lung cancer is the second most common type of cancer and the number one cause of cancer-related death around the world. Non-small lung cancer accounts for approximately 80-85% of all lung cancers.

Molecular makeup

By using biomarkers to identify a person’s particular tumour type, treatment can become more personalised and effective, since the molecular makeup of a person’s cancer often determines how they respond to different therapies.

In the trial on treatment-naïve patients, the objective response rate was 75%, and 59% of the patients responded for at least 12 months. 

Previously treated patients clocked a 46% rate, and 33% of the patients responded for at least a year.

The trial demonstrated that these patients could benefit from the combination therapy “targeted therapy regardless of their prior treatment history,” said Gregory Riely, MD, PhD, Vice Chair, Clinical Research in the Department of Medicine at Memorial Sloan Kettering Cancer Center and trial investigator.

Abdominal pain, rash

The most common adverse reactions observed in the trial were fatigue, nausea, diarrhoea, musculoskeletal pain, vomiting, abdominal pain, visual impairment, constipation, dyspnea, rash, and cough. 

A total of 17% of patients experienced an adverse reaction that resulted in permanent discontinuation of Mektovi and 16% experienced an adverse event that resulted in permanent discontinuation of Braftovi.

Serious adverse reactions, including dyspnea, pneumonia, arrhythmia, device-related infection, oedema, myocardial infarction, and pleural effusion occurred in 38% of patients.

Fatal adverse reactions occurred in 2% of patients, including intracranial haemorrhage and myocardial infarction.

Braftovi is FDA-approved, in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer, according to the statement.

Pfizer has exclusive rights to Braftovi and Mektovi in the US, Canada, and all countries in Latin America, Africa, and the Middle East. 

Ono Pharmaceutical Co., Ltd. has exclusive rights to commercialise both products in Japan and South Korea, Medison has exclusive rights in Israel, and Pierre Fabre has exclusive rights in all other countries, including Europe and Asia-Pacific.

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