Chris Ryan

The European Commission has approved subcutaneous amivantamab in multiple indications in advanced EGFR-mutant non–small cell lung cancer.

The European Commission approved trastuzumab deruxtecan for HR-positive, HER2-low or -ultralow metastatic breast cancer after at least 1 endocrine therapy.

Brexu-cel demonstrated clinical activity and safety in patients over 70 years of age with relapsed/refractory mantle cell lymphoma.

Orca-T improved moderate-to-severe cGVHD–free survival vs conventional allogenic transplant in advanced hematologic malignancies.

Silmitasertib generated disease control in patients with locally advanced or metastatic basal cell carcinoma.

A donor-derived CAR T-cell therapy produced complete remissions, but survival was limited in relapsed/refractory T-cell lymphoma.

Tovecimig plus paclitaxel improved overall response rate vs paclitaxel alone in second-line advanced biliary tract cancer.

Orca-T was associated with a retrospective survival improvement vs post-transplant cyclophosphamide in advanced hematologic malignancies.

CAN-2049 plus prodrug and continued immune checkpoint inhibition showed a potential OS benefit in advanced non–small cell lung cancer.

The EMA’s CHMP recommended the approval of first-line tislelizumab plus chemotherapy for extensive-stage small cell lung cancer.

The FDA approved perioperative durvalumab plus chemotherapy for muscle-invasive bladder cancer.

The FDA has expanded the indication for lutetium Lu 177 vipivotide tetraxetan for use in additional patients with PSMA-positive metastatic castration-resistant prostate cancer.

The EMA’s CHMP has recommended the approval of perioperative nivolumab plus chemotherapy in resectable PD-L1–positive non–small cell lung cancer.

Nirogacestat sustained long-term efficacy with acceptable safety in patients with desmoid tumors treated in the phase 3 DeFi trial.

Olvi-vec plus chemotherapy led to disease control in extensive-stage small cell lung cancer that was relapsed/refractory to platinum chemotherapy.

The FDA has approved TLX007-CDx as an imaging agent in select patients with prostate cancer.

The FDA granted fast track designation azercabtagene zapreleucel for relapsed/refractory diffuse large B-cell lymphoma.

The FDA approved pembrolizumab, trastuzumab, and chemotherapy for HER2-positive, PD-L1–positive gastric/GEJ adenocarcinoma.

The combination of avutometinib and defactinib produced durable responses in recurrent low-grade serous ovarian cancer.

The European Commission approved durvalumab for limited-stage small cell lung cancer without disease progression following chemoradiation.

Orca-T led to an improvement in chronic graft-vs-host disease–free survival in patients with advanced hematologic malignancies.

Luveltamab tazevibulin was active and safe in patients with platinum-resistant ovarian cancer and a FRα expression of at least 25%.

Micro-array needles containing doxorubicin displayed safety and early activity in basal cell carcinoma of the skin.

AVA6000 showed early efficacy and safety signals in previously treated, locally advanced or metastatic salivary gland cancers.

Amivantamab plus lazertinib was approved in Canada for first-line EGFR-mutated locally advanced or metastatic non–small cell lung cancer.

T-DXd with or without pertuzumab produced responses in first-line, HER2-positive metastatic breast cancer.

China’s NMPA has accepted an MAA seeking the approval of foritinib for ALK-positive advanced non–small cell lung cancer.

PF-07248144 plus fulvestrant was safe and generated responses in pretreated estrogen receptor–positive, HER2-negative metastatic breast cancer.

Perioperative durvalumab plus FLOT improved event-free survival in resectable gastric or gastroesophageal junction cancer.

The FDA has granted orphan drug designation to bexmarilimab for myelodysplastic syndromes.