Rivoceranib

FDA accepted Elevar Therapeutics' NDA resubmission for rivoceranib plus camrelizumab as a frontline treatment for uHCC, with a PDUFA date of March 20, 2025. The phase 3 CARES-310 study showed a median OS of 23.8 months with the combination vs 15.2 months with sorafenib, and a median PFS of 5.6 months vs 3.7 months, respectively.

The FDA accepted a resubmission of an NDA for frontline rivoceranib plus camrelizumab for unresectable or metastatic HCC, with a target action date of March 20, 2025. The resubmission followed a complete response letter citing manufacturing practice deficiencies. Data from the phase 3 CARES-310 trial showed significant OS improvements with the combination compared to sorafenib.

FDA accepts Elevar Therapeutics' NDA resubmission for rivoceranib + camrelizumab as first-line treatment for uHCC, with a PDUFA target action date of March 20, 2025. The resubmission is supported by the final survival analysis of the CARES-310 study, which showed significant improvements in overall survival.

The FDA accepted the resubmission of an NDA for rivoceranib and camrelizumab as a first-line treatment for uHCC, with a PDUFA target action date of March 20, 2025. The combination, an oral VEGF TKI and a PD-1 inhibitor, showed a median overall survival of 23.8 months in the CARES-310 study, the longest in a global phase 3 trial for this patient population.

The FDA accepted the NDA resubmission for the first-line use of rivoceranib and camrelizumab in unresectable or metastatic HCC, with a target action date of March 20, 2025. The resubmission followed a CRL citing manufacturing practice deficiencies and incomplete inspections. Data from the phase 3 CARES-310 trial showed significant OS improvements with the combination, with a manageable safety profile.

Elevar Therapeutics announced FDA acceptance of the resubmission of a new drug application for rivoceranib, an oral VEGF-TKI, in combination with camrelizumab, a PD-1 inhibitor, as a first-line systemic treatment for unresectable or metastatic hepatocellular carcinoma (uHCC). The FDA assigned a PDUFA target action date of March 20, 2025. The combination demonstrated significant improvements in overall survival and a manageable safety profile in the CARES-310 trial.

References discuss hepatocellular carcinoma (HCC) management, including guidelines, treatments like sorafenib, regorafenib, ramucirumab, cabozantinib, pembrolizumab, and apatinib, and clinical trials evaluating these treatments.

In September 2024, the FDA approved multiple oncology treatments, including subcutaneous atezolizumab, ribociclib for early breast cancer, isatuximab for multiple myeloma, selpercatinib for medullary thyroid cancer, and osimertinib for advanced NSCLC. Other approvals included OBX-115 for melanoma, FoundationOne CDx and Liquid CDx for prostate cancer, subcutaneous bortezomib, IBI363 for melanoma, 212Pb VMT01 for melanoma, ABD-147 for neuroendocrine carcinoma, certepetide for cholangiocarcinoma, tebapivat for myelodysplastic syndromes, elraglusib for soft tissue sarcoma, VNX-101 for leukemia, P-BCMA-ALLO1 for multiple myeloma, adjuvant ribociclib for breast cancer, pembrolizumab for mesothelioma, ICT01 for leukemia, CF33-hNIS for cholangiocarcinoma, trastuzumab-strf, amivantamab for NSCLC, CD-001, isatuximab for multiple myeloma, EO-3021 for gastric cancer, camrelizumab for HCC, LP-184 for rare pediatric tumors, osimertinib for NSCLC, and selpercatinib for medullary thyroid cancer.

Vironexis Biotherapeutics' VNX-101, an AAV vector-based gene therapy, received FDA clearance for a phase 1/2 trial in CD19+ acute lymphoblastic leukemia. CARsgen completed patient enrollment in a pivotal phase 2 trial for satricabtagene autoleucel in China for advanced gastric/gastroesophageal cancer. Adaptimmune's TCR T-cell therapy afami-cel received FDA approval for synovial sarcoma. Mustang Bio's MB-106 CAR-T therapy achieved a 90% response rate in Waldenstrom macroglobulinemia patients. Wugen's WU-CART-007 showed improved overall response rates with an enhanced lymphodepletion regimen in T-cell malignancy patients.

ODAC voted against PD-1 inhibitors in HER2-, MSS gastric/GEJ adenocarcinoma with PD-L1 < 1. Camrelizumab plus rivoceranib NDA resubmitted for unresectable HCC. FDA approved osimertinib for locally advanced, unresectable EGFR+ NSCLC after chemoradiation. ODAC also voted against anti-PD-1 therapy in metastatic/unresectable ESCC with PD-L1 < 1. FDA granted selpercatinib approval for RET fusion+ medullary thyroid cancer.