Biologics

Junshi Bio Inspection to Advance Toripalimab BLA

FDA has completed a previously delayed pre-licensing inspection of China-based Shanghai Junshi Biosciences’ toripalimab manufacturing site. The product is being developed by Coherus BioSciences and Junshi for treating recurrent or metastatic nasopharyngeal carcinoma (NPC). Coherus says the inspection concluded with a three-item FDA Form-483. It says that these are “readily addressable” and a response to the 483 will be submitted in early June.

FDA previously communicated (see earlier story) to the companies that an on-site inspection of the Junshi Biosciences manufacturing facility for toripalimab was required before their stalled BLA could be approved. The agency indicated it could not inspect the site during the previous review cycle due to the impact of Covid-19 travel restrictions involving China.

Toripalimab is described as an anti-PD-1 monoclonal antibody that blocks PD-L1 binding to the PD-1 receptor at a unique site that minimizes opportunities for the tumor cell to evade the immune system and decreases PD-1’s expression on the T-cell as a second method of restoring the body’s immune response.

FDA has granted priority review for the BLA for use in combination with gemcitabine and cisplatin as first-line treatment for patients with advanced recurrent or metastatic NPC and as monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy. The agency also granted breakthrough therapy status for second- or third-line treatment of metastatic NPC. And it has given toripalimab fast track designation to treat mucosal melanoma and orphan drug designation to treat NPC, mucosal melanoma, soft tissue sarcoma, and small cell lung cancer.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome