Roche’s immunotherapy cancer drug given FDA approval

pharmafile | October 19, 2016 | News story | Research and Development Cancer, FDA, Genentech, Roche, immunotherapy, lung cancer 

Coming off the back of earlier positive news this month, Roche has revealed that their drug, Tecentriq, has been given FDA approval for treatment of metastatic non-small cell lung cancer. The figures released earlier this month showed that those taking the drug lived a median of 13.8 months, which worked out, on average, as 4.2 months longer than those being treated with chemotherapy.

Tecentriq’s approval comes as the field of immunotherapy treatment has begun to spark something of an arms race between the companies developing such drugs. The market leader, Bristol-Myers Squibb’s Opdivo, released details of sales hitting $1.58 billion this year but Tecentriq is expected to now be able to take a share of this. Analysts expect Tecentriq’s sales across all cancer indications to reach $4 billion in 2021.

Regardless of the winners and losers in the race, immunotherapies are a promising area of development for those suffering from cancer – particularly those who are suffering from lung cancer, which is responsible for 20% of worldwide deaths to cancer. Roche plans on furthering expanding the uses for Tecentriq, with a further 15 clinical trials underway for treatment of lung cancer – seven of which are in Phase III.

“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” said Sandra Horning, M.D., Chief Medical Officer and Head of Global Product Development of Roche. “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.” 

“Tecentriq provides these patients with a new therapy targeting the PD-L1 pathway,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “Products that block PD-1/PD-L1 interactions are part of an evolving story about the relationship between the body’s immune system and its interaction with cancer cells.”

Ben Hargreaves

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