Bristol-Myers Squibb Co.'s cancer drug Opdivo received approval to treat patients with head and neck squamous cell carcinoma in China, the company confirmed in an email.
The PD-1 drug belongs to a class of immunotherapy that aims to treat cancer by boosting the body's immune system through blocking the interactions between T cells and cancer cells. More than 650,000 cases of head and neck cancer are recorded worldwide every year.
Opdivo received the regulatory nod from the U.S. Food and Drug Administration to treat advanced squamous cell cancer of the head and neck in 2016. The drug first entered China in 2018 as a therapy for non-small cell lung cancer.
Chinese regulators have granted approval to five PD-1 class of check point inhibitors so far— Opdivo, Merck & Co. Inc.'s Keytruda, Shanghai Junshi Biosciences Co. Ltd.'s melanoma therapy Tuo Yi, Innovent Biologics Inc.'s blood cancer drug Tyvyt and Jiangsu Hengrui Medicine Co. Ltd.'s blood cancer therapy camrelizumab.
Keytruda and Opdivo, the only two PD-1 drugs by multinational drugmakers approved in China, both received green lights for expanded use in the country recently. Keytruda is now approved to be used as a monotherapy for patients with non-small cell lung cancer whose tumors have a specific expression of the PD-L1 protein, with no EGFR or ALK genomic tumor aberrations.
China records more than 787,000 new cases of lung cancer every year, and non-small cell lung cancer is the most common type of lung cancer, accounting for about 85% of all cases.
"We're seeing the steady drumbeat of new approvals that gives us a lot of hope for the future," Merck's chief marketing officer Michael Nally said at the Cantor Fitzgerald Global Healthcare Conference in New York on Oct. 2 regarding the approval in China.
Brad Loncar, a biotech investor and CEO of Loncar Investments, said it is "big" that Keytruda has won the approvals for non-small cell lung cancer in China. However, he said there is still uncertainty around whether Keytruda and Opdivo can secure places on China's national drug reimbursement list, which will be revealed soon.
"First, it is unclear how the government will handle the competitive landscape of different indications. Second, we don't know if multinationals will be able politically to go low enough to suit the Chinese government without impacting their global business. These types of key questions will likely be answered very soon," Loncar said.

