Kristi Rosa

The FDA has issued a CRL to the BLA seeking approval of linvoseltamab for use in select patients with relapsed or refractory multiple myeloma.

GSK5764227 has received breakthrough therapy designation from the FDA for use in select patients with extensive-stage small cell lung cancer.

An NDA seeking approval of sacituzumab tirumotecan for select patients with EGFR+ non–small cell lung cancer has been accepted by the NMPA's CDE.

The European Commission has granted conditional marketing authorization to epcoritamab for patients with relapsed or refractory follicular lymphoma.

The FDA has granted orphan drug designation to PT217 for the treatment of patients with neuroendocrine carcinoma.

The EMA has expanded the indication for lisocabtagene maraleucel to include the treatment of patients with relapsed or refractory follicular lymphoma.

Enzalutamide led to improved OS, PCS, TTS, and TTR vs abiraterone acetate in patients with metastatic castration-resistant prostate cancer.

AC699 has won fast track designation from the FDA for select patients with ER-positive, HER2-negative, ESR1-mutated breast cancer.

Vebreltinib demonstrated preliminary activity in patients with non–central nervous system solid tumors harboring MET fusions.

A sNDA seeking the approval of toripalimab for frontline use in patients with unresectable or metastatic melanoma is under review by the NMPA.

Devimistat and modified fluorouracil, oxaliplatin, irinotecan, and leucovorin did not significantly improve short- or long-term outcomes over standard-dose FFX in metastatic pancreatic adenocarcinoma

Trastuzumab deruxtecan elicited responses in patients with HER2-positive biliary tract cancer, according to data from a single-arm, phase 2 trial.

The FDA granted an orphan drug designation to the combination of avutometinib and defactinib for use as a potential therapeutic option in patients with pancreatic cancer.

The FDA approved Darzalex Faspro plus VRd for induction and consolidation in select patients with newly diagnosed multiple myeloma.

Frontline pembrolizumab, carboplatin, and paclitaxel demonstrated antitumor activity in recurrent or metastatic head and neck squamous cell carcinoma.

The EMA's CHMP has recommended zolbetuximab plus chemotherapy in select locally advanced unresectable or metastatic HER2-negative gastric or GEJ cancer.

NICE recommends pembrolizumab plus platinum- and fluoropyrimidine-based chemotherapy for untreated HER2-negative advanced gastric or GEJ adenocarcinoma.

Atezolizumab administered before and following chemoradiation appeared to be safe and efficacious in unresectable stage III non–small cell lung cancer.

Bintrafusp alfa elicited responses in patients with recurrent/metastatic cervical cancer, warranting further exploration of TGF-β-targeted therapies.

The marketing authorization application seeking the approval of vimseltinib for the treatment of tenosynovial giant cell tumor is under EMA review.

The EMA has accepted a marketing authorization application seeking approval of belantamab mafodotin regimens in relapsed/refractory multiple myeloma.

RMC-6236 led to early antitumor activity with an acceptable safety profile in patients with previously treated pancreatic ductal adenocarcinoma.

The FDA has granted fast track designation to CT-0525 for the treatment of patients with HER2-overexpressing solid tumors.

Treatment with single-agent abemaciclib (Verzenio) did not demonstrate clinically meaningful activity in heavily treated patients with metastatic clear cell renal cell carcinoma.

Paxalisib improved OS over SOC in patients with newly diagnosed glioblastoma and unmethylated MGMT promotor status.

Data from the phase 2 REGINA trial support further investigation of neoadjuvant regorafenib, nivolumab, and SCRT in locally advanced rectal cancer.

Here is your guide to the important regulatory decisions made by the FDA in June 2024.

The EMA recommends durvalumab plus chemotherapy, followed by olaparib and durvalumab for pMMR endometrial cancer, and single-agent durvalumab for dMMR disease.

The EMA's CHMP has adopted a positive opinion regarding erdafitinib in patients with FGFR3+ unresectable or metastatic urothelial carcinoma.

The FDA has approved a new drug application for Tepylute, a ready-to-dilute formulation to treat breast and ovarian cancers.