Drugs

Liver Cancer Combo Gets 2nd Complete Response Letter

Pharmaceutical company HLB and China’s Antengene say FDA has issued a second complete response letter (CRL) on rivoceranib, an oral VEGF-TKI, in combination with camrelizumab, a PD-1 inhibitor, as a first-line systemic treatment for unresectable or metastatic liver cancer. In May, FDA issued a complete response letter that cited chemistry, manufacturing, and controls deficiencies found during a recent inspection, according to the companies. It also indicated that due to travel restrictions, inspections at key clinical trial sites in Russia and Ukraine had not been completed.

HLB chairman Jin Yang-gon said: “The first CRL in May last year was for two issues: the manufacturing and quality control (CMC) of camrelizumab, but this CRL is solely because the CMC issues with camrelizumab have not been sufficiently resolved,” according to Korean news outlet ChosunBiz. The CRL does not specifically state what the deficiencies are and he added: “Antengene will quickly contact the FDA to identify what specific content needs to be addressed before responding.”

Riboceranib is a targeted cancer drug developed by Elevate, a subsidiary of HLB, while camrelizumab is an immune checkpoint inhibitor from Antengene. Immune checkpoint inhibitors prevent cancer cells from disguising them as normal cells, allowing them to be attacked by immune cells.

The NDA was resubmitted 10/2024 and it includes the final analysis of the Phase 3 CARES-310 study that showed median overall survival of 23.8 months, the longest for any treatment in a global Phase 3 trial for patients with unresectable or metastatic liver cancer, according to the companies. “The data also demonstrated consistent efficacy across patients with both viral and non-viral etiologies,” they say.

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

Read more

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