NMPA (China) approves Cosela to decrease the incidence of chemotherapy-induced myelosuppression for extensive-stage small cell lung cancer.
G1 Therapeutics, Inc. announced that the China National Medical Products Administration (NMPA) has conditionally approved Cosela (trilaciclib hydrochloride for injection), which was jointly developed for use in Greater China by Simcere and G1 Therapeutics.
Cosela is now indicated in China to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen for extensive-stage small cell lung cancer. As a result of receiving approval in China, G1 will receive a $13 million milestone payment. In total, G1 may receive up to $156 million in total milestones. G1 may also receive double-digit royalties on annual net sales of Cosela in China.
It is predicted that, by 2040, the number of new cancer patients requiring chemotherapy in China will reach 4.2 million. While chemotherapy remains the cornerstone of treatment for many cancer types, its toxic side effects have widespread impact on patients and can lead to dose reductions or delays, both of which diminish its therapeutic effect. According to Chinese statistics, myelosuppression is associated with more than 80% of chemotherapy drugs. G1 has partnered with Simcere to jointly conduct clinical trials of trilaciclib in colorectal cancer and triple negative breast cancer.