The U.S. Food and Drug Administration (FDA) has granted accelerated approval for pembrolizumab (Keytruda) for the treatment of patients with advanced (metastatic) non-small cell lung cancer (NSCLC) whose disease has progressed after other treatments and with tumors that express the programmed death-ligand 1 (PD-L1) protein.
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Keytruda and another similar treatment from Bristol-Myers Squibb Co called Opdivo are antibodies created to block the interaction between PD-L1 and another protein, PD-1, whose natural function is to put checks on the immune system. But Roche ($RHHBY) could quickly come in and complicate matters; its atezolizumab is coming on strong with a “breakthrough” designation in lung cancer and potential approval next year. Lung cancer is also by far the leading cause of cancer death in the U.S. About 85 percent to 90 percent of lung cancers are classified as non-small cell. “This important news means that we now have a new immunotherapy option to help patients with squamous and non-squamous metastatic non-small cell lung cancer with disease progression on or after platinum-containing chemotherapy and whose tumors express PD-L1”. Non-small cell lung cancer is the most common type of lung cancer.
Shares of Merck were down 0.3 percent at $49.22 in afternoon trading Friday on the New York Stock Exchange. By blocking the interaction, the drugs aim to enable the patient’s own immune system to attack the cancer. The two-drug combination would cost about $256,000 for the first full year. In May, Leonard Saltz, an oncologist from Memorial Sloan Kettering Cancer Center called prices for new cancer drugs “unsustainable” in a speech at a meeting of cancer doctors. The most common side effects included fatigue, loss of appetite, impaired breathing and cough.
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“I think there’s going to be more and more interest on the part of oncologists in using PD-L1 expression in making decisions about how best to treat their lung-cancer patients”, Merck’s Dr. Perlmutter said.
