Roche's Tecentriq gains first approval in China as treatment for extensive-stage small-cell lung cancer

Ref: Yicai Global;NASDAQ;ShareCast;Roche

Roche announced Friday that China's National Medical Products Administration (NMPA) approved Tecentriq (atezolizumab) in combination with chemotherapy for the first-line treatment of patients with extensive-stage small-cell lung cancer (SCLC). The company noted that the clearance marks the first approval for a Tecentriq-based therapy in China.

"This approval makes Tecentriq the first cancer immunotherapy available in China for the initial treatment of extensive-stage SCLC less than a year after theā€¦FDA and [European Medicines Agency] approvals," remarked Levi Garraway, head of global product development. The drug, which inhibits PD-L1, is also under review in China, in combination with Avastin (bevacizumab), for the treatment of patients with unresectable hepatocellular carcinoma who have not received prior systemic therapy.

According to Roche, the approval in China for extensive-stage SCLC is based on results from the Phase III IMpower133 study, which showed that Tecentriq in combination with chemotherapy helped patients live significantly longer compared with chemotherapy alone, with respective median overall survival of 12.3 months and 10.3 months. In addition, the combination of Tecentriq and chemotherapy was associated with progression-free survival of 5.2 months, which was significantly longer than the 4.3 months achieved among those in the comparator group.

Last month, Roche announced that Tecentriq generated sales of CHF 578 million ($589 million) in the fourth quarter of 2019, representing year-on-year growth of 136%. The drugmaker is conducting a number of Phase III studies for Tecentriq across lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers.