oncology

The FDA approved Celcuity's gedatolisib for PIK3CA wild-type HR+/HER2- advanced breast cancer after it more than tripled progression-free survival over fulvestrant alone in the Phase 3 VIKTORIA-1 trial.

The FDA cleared a subcutaneous, wearable-device formulation of Sanofi's multiple myeloma drug Sarclisa, the first cancer therapy approved for on-body injector delivery.

Roche says its next-generation inhibitor divarasib improved both progression-free and overall survival versus approved KRAS G12C drugs in a 338-patient Phase 3 NSCLC trial.

Pfizer's integrin beta-6 ADC failed to beat docetaxel on overall survival across the full SigVie-002 population, but showed a stronger trend in the two-thirds of patients with one prior line of therapy.

Cogent's bezuclastinib plus sunitinib reached 16.5-month median PFS versus 9.2 months in second-line GIST, with FDA Priority Review and a November 30 PDUFA date.

The SENTRY trial of selinexor plus ruxolitinib met its spleen-volume endpoint and missed its symptom endpoint, with an immature overall survival signal favoring the combination.

Corcept's relacorilant plus nab-paclitaxel cut the risk of death 35% in platinum-resistant ovarian cancer, raising median survival to 16 months from 11.9, with the phase 3 ROSELLA results published in The Lancet.

Five-year overall survival was non-inferior when surgeons omitted completion axillary dissection, while severe arm problems fell from 12.6% to 3.6%.

The 4,429-patient Phase III OPTIMA trial found that a Prosigna ROR-guided strategy was non-inferior to standard chemotherapy in ER-positive, HER2-negative early breast cancer, letting 68% of clinically high-risk patients skip chemo.

IGNYTE trial data show 83.5% of responders alive at three years; Replimune plans third BLA resubmission after two FDA rejections.

AbbVie's pivekimab sunirine-pvzy wins FDA approval for BPDCN on May 27, with a 69.7% complete remission rate in newly diagnosed patients and the first-ever outpatient initiation for this ultra-rare malignancy.

The FDA on May 13 cleared Taiho Oncology's Inqovi combined with venetoclax as the first fully oral treatment for older or unfit AML patients, replacing injection-based clinic visits.