Soon after FDA granted accelerated approval for atezolizumab (Tecentriq, Genentech) to treat bladder cancer, the agency okayed the drug to treat metastatic non-small cell lung cancer (NSCLC).
Soon after FDA granted accelerated approval for atezolizumab (Tecentriq, Genentech) to treat bladder cancer, the agency apporoved the drug to treat metastatic non-small cell lung cancer (NSCLC).
This spring, FDA approved Tecentriq as the first drug for bladder cancer that utilizes the body’s immune system. “Tecentriq is a new medicine that can work with the immune system to treat people with a type of bladder cancer that progressed after platinum-based chemotherapy,” said Sandra Horning, MD, chief medical officer and head of Global Product Development at Genentech.
Related: Why new bladder cancer drug is novel
Now, Roche-owned Genentech has been able to show that Tecentriq helped patients in Phase II and Phase III studies live a median of 13.8 months, 4.2 months longer than those treated with docetaxel chemotherapy. The drug is specifically for patients with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities.
“Tecentriq is a new option to help people with this type of previously treated metastatic lung cancer, regardless of PD-L1 expression, live longer than chemotherapy,” Horning said. “Tecentriq is the first and only approved cancer immunotherapy designed to target the PD-L1 protein, which may play an important role in the way the medicine works.”
Related: FDA expands drug to treat NSCLC
The Tecentriq development program includes more than 15 clinical trials in lung cancer, including seven Phase III studies in previously untreated (first-line) lung cancer. These studies are evaluating the use of Tecentriq alone or in combination with other medicines.
Possible serious side effects with Tecentriq include, but are not limited to, lung problems (pneumonitis), liver problems (hepatitis), intestinal problems (colitis), hormone gland problems (especially the pituitary, thyroid, adrenal glands and pancreas), nervous system problems (neuropathy, meningitis and encephalitis), eye problems (inflammation of the eyes), severe infections and severe infusion reactions.
FDA Clears Phase 2 Trial of Cannabis in PTSD
November 20th 2024After a three-year negotiation, the FDA has dropped its objection to allowing patients to self-titrate dosing of smoked cannabis. But regulators want to see additional information about the device that will be used for inhalation.
Read More