FDA clears subcutaneous RYBREVANT FASPRO for first-line EGFR+ NSCLC: What this changes for patients and providers

FDA clears subcutaneous RYBREVANT FASPRO for first-line EGFR+ NSCLC: What this changes for patients and providers

The U.S. Food and Drug Administration has approved Johnson & Johnson’s RYBREVANT FASPRO (amivantamab and hyaluronidase-lpuj), the first subcutaneous version of its bispecific EGFR-MET antibody therapy, for patients with EGFR-mutated non-small cell lung cancer (NSCLC). The approval spans all current RYBREVANT indications and is based on the Phase 3 PALOMA-3 study, which demonstrated comparable pharmacokinetics […]

Can Harbour BioMed’s deal with Bristol Myers Squibb redefine the future of multispecific antibodies?

Can Harbour BioMed’s deal with Bristol Myers Squibb redefine the future of multispecific antibodies?

Harbour BioMed has signed a global strategic collaboration and license agreement with Bristol Myers Squibb to discover and develop next-generation multispecific antibodies. The deal could be worth over $1.1 billion across upfront payments, milestones, and royalties. It also signals growing interest in platforms capable of generating novel immunotherapies for complex diseases. The announcement is not […]

Can Akeso’s cadonilimab unlock PD-L1-agnostic immunotherapy for gastric cancer patients?

Can Akeso’s cadonilimab unlock PD-L1-agnostic immunotherapy for gastric cancer patients?

Akeso Inc. has secured clearance from the United States Food and Drug Administration to initiate COMPASSION-37, a global Phase III trial evaluating cadonilimab, a first-in-class PD-1/CTLA-4 bispecific antibody, as part of a first-line treatment regimen for HER2-negative, unresectable or metastatic gastric and gastroesophageal junction adenocarcinoma. The randomized, multicenter trial will compare cadonilimab plus chemotherapy against […]