- In May 2024, the FDA accepted a Biologics License Application (BLA) for nivolumab (Opdivo) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20), seeking approval for subcutaneous nivolumab. This treatment is intended for patients with previously approved solid tumor indications for nivolumab as a monotherapy, as maintenance therapy after combination therapy with nivolumab and ipilimumab (Yervoy), or in combination with chemotherapy or cabozantinib
- In January 2024, Coherus BioSciences, Inc. announced that LOQTORZI (toripalimab-tpzi) is now available through select specialty distributors in the U.S. This drug is approved for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC) in combination with cisplatin and gemcitabine, as well as for the treatment of adults with recurrent, unresectable, or metastatic NPC who have disease progression on or after platinum-containing chemotherapy
- In October 2023, Craig Gordon, CEO of GordonMD Global Investments LP, revealed that his firm had jointly invested in a private placement financing for Radionetics Oncology, a clinical-stage pharmaceutical company focused on developing novel radiotherapeutics for various oncology indications. Radionetics, spun out of Crinetics Pharmaceuticals in 2021, is supported by investors including Frazier Healthcare, 5AM Ventures, and Crinetics Pharmaceuticals
- In November 2021, Merck announced that KEYTRUDA, its anti-PD-1 therapy, was approved by the Japan Pharmaceuticals and Medical Devices Agency (PMDA) for the first-line treatment of patients with radically unresectable, advanced, or recurrent esophageal carcinoma. This approval was based on data from the Phase 3 KEYNOTE-590 trial, where KEYTRUDA was used in combination with chemotherapy (5-fluorouracil [5-FU] plus cisplatin)
