Roche's lung cancer drug wins US approval
CALIFORNIA - Swiss drugmaker Roche Holding AG's new immunotherapy, Tecentriq, won approval from US health regulators as a second-line lung cancer treatment, a decision seen likely to erode Bristol-Myers Squibb's position in this hotly contested market.
The US Food and Drug Administration approved Tecentriq to be used in non-small cell lung cancer patients previously treated with chemotherapy, regardless of whether their tumors express a protein called PD-L1. People with high PD-L1 levels are generally more receptive to immunotherapy.
In study results released this month, patients getting Tecentriq lived on average 4.2 months longer than those taking chemotherapy.
Tecentriq is aiming for a share of the treatment market now dominated by Bristol's Opdivo, a drug which doctors can also prescribe for patients regardless of their levels of immune-system suppressing PD-L1 expression.
In the first half, Opdivo sales hit $1.58 billion, about three times that of Merck & Co's drug, Keytruda, that is prescribed only for people who express a certain level of PD-L1.
Analysts estimate Tecentriq's annual sales across all cancers - it is already approved for bladder cancer and will seek approval for more indications - will reach $4 billion in 2021, according to consensus figures compiled by Thomson Reuters.
Tecentriq, Opdivo and Keytruda are the initial entrants in a highly promising class of immunotherapy drugs now transforming cancer treatment and are jockeying for pole position, either for use alone or in combination with other drugs. -Reuters