PD-1/PD-L1

Sep 23, 2024

Better late than never for FDA approval of the first subcutaneous PD-L1 inhibitor—Roche’s TECENTRIQ HYBREZA—after manufacturing delays disrupted the company’s initial launch plans last year. The FDA was originally set to decide on TECENTRIQ’s under-the-skin formulation in September, but Roche’s delivery technolo...

Jun 14, 2024

Bristol Myers Squibb’s PD-1 inhibitor, OPDIVO, has deep roots in Japan. In July 2014, MHLW approved OPDIVO to treat melanoma, marking it the first approved PD-1 inhibitor globally. About two years later, KEYTRUDA gained approval in Japan for the same indications (melanoma and NSCLC). This set the stage for fierce c...

Jun 03, 2024

Immune checkpoint inhibitors (ICIs) are currently among the most widely used treatments for cancer. Chinese pharmaceutical companies have been making significant strides in developing PD-1 and PD-L1 inhibitors, used to treat various cancers. Several of these companies are now entering or planning to enter the US an...