The FDA has granted accelerated approval to Bristol Myers Squibb ZENBEXUS (iberdomide), the first CELMoD therapy ever cleared, paired with daratumumab and dexamethasone for multiple myeloma patients as early as first relapse.
The European Commission has approved Merck’s Erbitux BRAF V600E mCRC combination regimen cetuximab plus encorafenib and FOLFOX as first-line therapy for metastatic colorectal cancer with the BRAF V600E mutation, based on Phase 3 BREAKWATER data showing a 51% reduction in risk of death versus standard chemotherapy.
AstraZeneca has secured exclusive worldwide rights to Zegfrovy (sunvozertinib), Dizal Pharmaceutical’s oral EGFR inhibitor for EGFR exon 20 insertion non-small cell lung cancer, in a deal worth up to $1.5 billion. The agreement strengthens AstraZeneca’s EGFR-mutated lung cancer portfolio ahead of potential first-line expansion.
The FDA has approved PADCEV plus Keytruda as the first platinum-free neoadjuvant and adjuvant regimen for adults with muscle-invasive bladder cancer, regardless of cisplatin eligibility, backed by Phase 3 EV-304 data showing major reductions in recurrence and death risk.
Sanofi’s Sarclisa Escena has been approved by the FDA as the first anticancer treatment deliverable via an on-body injector, offering multiple myeloma patients a faster, needle-free-feeling alternative to IV infusions.
Roche’s next-generation KRAS G12C inhibitor, divarasib, has achieved statistical significance in a global head-to-head Phase III trial against sotorasib and adagrasib for advanced non-small cell lung cancer.
AstraZeneca and Daiichi Sankyo’s Datroway has received a positive CHMP recommendation in the European Union for the first-line treatment of adult patients with metastatic triple-negative breast cancer who are not candidates for immunotherapy.
Pfizer Inc. announced the landmark FDA expansion of IBRANCE (palbociclib) in combination with anti-HER2 and endocrine therapies for HR+, HER2+ metastatic breast cancer frontline maintenance following successful Phase 3 PATINA trial results.
Gilead Sciences announced that the European Commission has approved Trodelvy as a first-line monotherapy for adults with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitors, based on the landmark Phase 3 ASCENT-03 study.
Pfizer has announced topline Phase 3 results from its SigVie-002 study evaluating the investigational antibody-drug conjugate sigvotatug vedotin in previously treated metastatic non-squamous non-small cell lung cancer.
