FDA OKs immunotherapy drugs for bladder, blood cancers – ‘First major advance in three decades’

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TRENTON, NJ, May 19, (AP): US regulators have approved the fi rst drug for bladder cancer that harnesses the body’s immune system, the fi rst major advance in three decades against the most common type of bladder cancer. Tecentriq won accelerated approval Wednesday from the Food and Drug Administration for treating patients with advanced urothelial cancer after chemotherapy stops helping them — a point when most usually die within about six months. Such conditional approval is granted based on promising initial test results for disorders where patients have few or no options.

Testing on many more patients to confi rm the early results, which is required to obtain full approval from the FDA, is in progress. Tecentriq, developed by the Roche Group’s Genentech unit, blocks a protein found on many tumor cells that deactivates T-cells, the key immunesystem cells that hunt down and destroy cancer cells. A similar drug from Bristol-Myers Squibb Co, Opdivo, was approved by the FDA late Tuesday for treating Hodgkin lymphoma — the fourth cancer type for which it’s been approved in the US. Both drugs are part of a promising new class of injected cancer medicines that work with the patient’s own immune system, helping it fi nd and kill tumor cells that might otherwise multiply by using mechanisms to hide from immune-system sentinels.

Drugmakers are racing to develop such drugs to fi ght a range of deadly cancers, and some of the new drugs have brought the fi rst signifi cant improvements in patient survival in decades. In many hard-to-treat cancers, new drugs that extend survival just a few months for some patients are considered a big advance. Most bladder cancer patients for whom chemotherapy fails die within about six months on average, according to Dr Daniel Chen, Genentech’s head of development for so-called cancer immunotherapy drugs. Chen said in an interview that some patients given Tecentriq in clinical testing are alive as long as three years after starting treatment. The tests on which Tecentriq’s approval are based included 310 people with advanced urothelial cancer, which occurs in the bladder and sometimes in the ureter, urethra and pelvis.

The testing found 15 percent of the patients had their tumors shrink, with that benefi t lasting about 2 months to 14 months. In the subset of patients found to have high levels of the protein that Tecentriq targets, called PD-L1, 26 percent had their tumors shrink. Tumors completely vanished in nearly 6 percent of the patients tested, and in 12 percent of those with high levels of the PD-L1 protein. Those patients are still being followed, and many continue to do well. Chen noted that unlike chemotherapy, which often causes disabling nausea and other serious side effects, patients suffered far less-severe side effects while on Tecentriq.

Those ranged from various infections and fatigue to intestinal blockages and blood clots. “Many of these patients go back to work” during treatment, Chen said. “They’re able to experience a normal quality of life”. Chen said the additional study results also will be aimed at getting approval for using Tecentriq for newly diagnosed patients. Bladder cancer is the fi fth-most common type, and strikes far more men than women. There are about 77,000 new cases and 16,400 deaths per year in the US, according to the National Cancer Institute

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