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Lung Cancer Antibody Given FDA Breakthrough Tag

Lung cancer X-ray

(National Cancer Institute)

2 February 2015. An experimental engineered antibody for treating lung cancer received a breakthrough designation from the U.S. Food and Drug Administration. Genentech, a biotechnology subsidiary of drug maker Roche, says breakthrough status was granted for its cancer immunotherapy code-named MPDL3280A to treat programmed death-ligand 1 or PD-L1 positive non-small cell lung cancer whose disease has progressed during or after platinum-based chemotherapy.

Non-small cell lung cancer is the most common form of lung cancer, accounting for about 85 percent of all cases. American Cancer Society estimates more than 221,000 new cases of lung cancer will be diagnosed in the U.S. during 2015, affecting somewhat more men than women, leading to 158,000 deaths.

PD-L1 is a protein associated with a number of solid tumors, including this common type of lung cancer. MPDL3280A counteracts the PD-L1 protein’s ability to bind to receptors on T-cells, white blood cells in the body’s immune system. In addition, the company believes MPDL3280A helps activate T-cells, thus restoring their roles in the immune system of finding and attacking tumor cells.

Genentech is testing MPDL3280A with patients of skin (melanoma) and bladder as well as lung cancer, in early stage clinical trials, combined with currently approved cancer drugs bevacizumab, marketed as Avastin, or vemurafenib, brand-named Zelboraf. Intermediate-stage trials of MPDL3280A with lung cancer patients are in progress. In May 2014, FDA granted MPDL3280A breakthrough status for patients with metastatic bladder cancer, marked as PD-L1 positive.

The new breakthrough designation applies as well to MPDL3280A in patients with non-small cell lung cancer, characterized as PD-L1 positive, but also who whose disease progressed during or since treatments with platinum-based chemotherapy. Platinum increases the ability of chemotherapy drugs to bind to cellular DNA, and is often used to treat these kinds of cancer, but tumors can sometimes develop a resistance to it.

FDA assigns a breakthrough designation to therapies that address a serious condition and demonstrate through clinical evidence that the treatment is a substantial improvement over current methods. Once designated as a breakthrough therapy, a drug or biologic can receive early and frequent communications with FDA staff, quick resolution of questions, intensive guidance on drug development, and an organizational commitment from top managers.

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Hat tip: FirstWord Pharma

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