New MajesTEC-3 modeling from Johnson & Johnson finds that TECVAYLI plus DARZALEX FASPRO, used as early as second line, could give roughly 87% of relapsed/refractory multiple myeloma patients a mortality risk and life expectancy close to the general population, driven by a 90% drop in disease-progression risk versus standard of care.
Johnson & Johnson has reported pivotal Phase 3 findings for CAPLYTA (lumateperone) in bipolar mania, with the study showing significant and rapid improvement in manic symptoms.
Novo receives a positive CHMP opinion for once-weekly Sogroya® (somapacitan) to treat children with idiopathic short stature in Europe.
Novo has secured a positive CHMP opinion for FREHEMGO® (denecimig) to treat haemophilia A in adults and children, offering the first FVIIIa mimetic with once-monthly, bi-weekly, and weekly dosing options in a pre-filled pen.
Gilead Sciences accelerates global access planning for investigational once-yearly lenacapavir, expanding royalty-free generic licensing across 120 high-incidence countries alongside Phase 3 PURPOSE 365 trials.
Final PAPILLON trial results show Johnson & Johnson’s RYBREVANT (amivantamab-vmjw) plus chemotherapy achieved a 34.3-month median overall survival in EGFR exon 20 insertion-positive NSCLC — the longest reported to date in this historically hard-to-treat population.
Results from the AstraZeneca Enhertu DESTINY-Lung04 Trial show a 37% reduction in risk of disease progression or death, establishing first-line efficacy for T-DXd in HER2-mutant non-small cell lung cancer.
Roche’s collaborator MediLink reported phase III TAISHAN-302 data showing Tam-Peli (tambotatug pelitecan) reduced the risk of death by 54% versus topotecan in Chinese patients with relapsed small-cell lung cancer, meeting its primary endpoint with a favorable safety profile.
GSK’s B7-H3-targeted ADC Ris-Rez cut the risk of death by 54% versus topotecan in the Phase III ARTEMIS-008 trial in relapsed small cell lung cancer in China, with a median overall survival of 18.5 months and fewer severe side effects than chemotherapy.
AstraZeneca’s Phase III SERENA-4 trial of Etcamah (camizestrant) plus palbociclib missed statistical significance for progression-free survival in first-line advanced ER-positive breast cancer, though a numerical benefit was observed. The company says the miss sharpens its focus on ESR1-mutation-driven use of Etcamah under its existing SERENA-6 approval, with safety unchanged from each medicine’s known profile.
