FDA approves Merck’s Keytruda for advanced NSC lung cancer
pharmafile | October 5, 2015 | News story | Research and Development, Sales and Marketing | BMS, NSCL, keytruda, lung cancer, merck sharp and dohme, opdivo
The US Food and Drug Administration has granted accelerated approval for Merck’s Keytruda (pembrolizumab) to treat patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumours that express a protein called PD-L1.
Keytruda is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, the first test designed to detect PD-L1 expression in non-small cell lung tumours.
Lung cancer is the leading cause of cancer death in the United States, with an estimated 221,200 new diagnoses and 158,040 deaths in 2015, according to the National Cancer Institute. NSCLC is the most common type of lung cancer, accounting for up to 90% of cases.
Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, comments: “Our growing understanding of underlying molecular pathways and how our immune system interacts with cancer is leading to important advances in medicine. Today’s approval of Keytruda gives physicians the ability to target specific patients who may be most likely to benefit from this drug.”
Keytruda works by targeting the cellular pathway known as PD-1/PD-L1 (proteins found on the body’s immune cells and some cancer cells). It is believed that by blocking this pathway, the drug helps the body’s immune system fight the cancer cells.
In 2014, Keytruda was approved to treat patients with advanced melanoma following treatment with ipilimumab, a type of immunotherapy. Another drug, Opdivo (nivolumab), manufactured by Bristol-Meyers Squibb, which uses a similar mechanism of action to treat a specific form of NSCLC, squamous), was approved earlier this year.
Keytruda is the first drug to be approved for both squamous and non-squamous NSCLC.
The safety of Keytruda was studied in 550 patients with advanced NSCLC, with the most common side effects including fatigue, decreased appetite, shortness of breath or impaired breathing (dyspnea) and cough.
The drug’s approval was based on a study of patients with advanced NSCLC that progressed following platinum-based chemotherapy or, if appropriate, targeted therapy for certain genetic mutations (ALK or EGFR), tumours shrank in 41 percent of patients treated with Keytruda and the effect lasted between 2.1 and 9.1 months.
Nineteen percent of these patients’ tumours shrunk significantly.
Dr Roger Perlmutter, president, Merck Research Laboratories, comments: “Today’s approval of Keytruda is the result of our deep commitment to bring the benefits of immunotherapy to cancer patients. Together with scientists and physicians around the world, we endeavour to improve the lives of patients suffering from these grievous illnesses.”
The FDA granted Keytruda breakthrough therapy designation for this indication because Merck demonstrated through preliminary clinical evidence that the drug may offer a substantial improvement over available therapies. The drug also received priority review status, which is granted to drugs that, at the time the application was submitted, have the potential to be a significant improvement in safety or effectiveness in the treatment of a serious condition.
Keytruda was approved under the agency’s accelerated approval program, which allows the approval of a drug to treat a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients.
Joel Levy
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