Kristi Rosa

A sNDA seeking approval of enfortumab vedotin plus pembrolizumab for first-line use in patients with urothelial cancer has been submitted to Japan’s MHLW.

The combination of SCO-101 and FOLFIRI resulted in tumor reduction and increased progression-free survival in patients with metastatic colorectal cancer.

An acceptable safety profile and early evidence of clinical activity was observed with ziftomenib plus standard regimens in select patients with AML.

The FDA granted priority review to a sNDA seeking the approval of alectinib as adjuvant treatment after surgery for early-stage ALK-positive NSCLC.

Liso-cel sBLAs for indications in relapsed/refractory FL and MCL after exposure to a BTK inhibitor have received priority review from the FDA.

Pembrolizumab plus cabozantinib was efficacious in the first-line treatment of patients with cisplatin-ineligible urothelial carcinoma.

The EMA's CHMP has recommended the approval of idecabtagene vicleucel in patients with multiple myeloma who received at least 2 prior therapies.

KVA12123 demonstrated early signals of on-target activity and tolerability at all dose levels examined to date in patients with advanced solid tumors.

The FDA has accepted for review the BLA for obecabtagene autoleucel's use in patients with relapsed or refractory B-cell acute lymphoblastic leukemia.

The FDA has approved erdafitinib (Balversa) for select adult patients with locally advanced or metastatic urothelial carcinoma harboring FGFR3 alterations.

Durvalumab plus neoadjuvant FLOT improved pCR vs chemotherapy alone in patients with resectable gastric and GEJ cancers, irrespective of region.

A PMA application seeking approval of TTFields to standard therapies in patients with non­–small cell lung cancer has been accepted for filing by the FDA.

The European Medicines Agency has granted orphan drug designation to pimicotinib for use in patients with inoperable tenosynovial giant cell tumor.

An MAA seeking the approval of lazertinib plus amivantamab in the first-line treatment of adult patients with EGFR+ NSCLC has been submitted to the EMA.

The FDA has approved pembrolizumab (Keytruda) plus chemoradiation for patients with FIGO 2014 stage III to IVA cervical cancer.

The FDA has granted fast track designation to SLS009 for use in patients with relapsed or refractory acute myeloid leukemia.

The European Commission has granted conditional marketing authorization to adagrasib for patients with KRAS G12C+ advanced non–small cell lung cancer.

The FDA has granted priority review to a sBLA seeking to convert the accelerated approval of tisotumab vedotin to full approval in select patients with cervical cancer.

China’s NMPA has accepted the sNDA seeking the approval of cadonilimab plus chemotherapy for use in select patients with gastric or GEJ adenocarcinomas.

The FDA has granted breakthrough therapy designation to TAR-200 for use in the treatment of patients with Bacillus Calmette-Guérin–unresponsive, high-risk non–muscle invasive bladder cancer who are not candidates for or opted not to receive radical cystectomy.

The safety and efficacy data observed with the administration of 5 or more cycles of induction platinum/etoposide and concurrent durvalumab in patients with extensive-stage small cell lung cancer enrolled in the phase 3b LUMINANCE study aligned with outcomes reported in the phase 3 CASPIAN trial.

The FDA has granted fast track and breakthrough therapy designations to cretostimogene grenadenorepvec for use as a potential therapeutic option in patients with high-risk BCG-unresponsive non–muscle invasive bladder cancer with carcinoma in situ with or without Ta or T1 tumors.

A coformulation of vibostolimab and pembrolizumab with or without docetaxel failed to result in a statistically significant improvement in progression-free survival compared with docetaxel alone in patients with metastatic non­–small cell lung cancer.

The European Medicines Agency has validated its marketing authorization application for repotrectinib in adult patients with ROS1 TKI-naive or -pretreated locally advanced or metastatic non–small cell lung cancer harboring ROS1 fusions, as well as adult and pediatric patients with TKI-naive and pretreated NTRK-positive locally advanced or metastatic solid tumors.

The FDA has granted fast track designation to aglatimagene besadenovec plus valacyclovir for use as a potential therapeutic option in patients with pancreatic ductal adenocarcinoma.

The National Medical Products Administration of China has approved sugemalimab paired with fluorouracil and platinum-based chemotherapy for use in the frontline treatment of patients with unresectable locally advanced, recurrent, or metastatic esophageal squamous cell carcinoma.

Maurie Markman, MD, discusses current challenges faced with developing robust decision support tools for oncologists and projects additional research efforts dedicated to finding a way to leverage CAR T-cell therapies in solid tumors to improve patient outcomes.

The European Commission has approved new indications for pembrolizumab in combination with chemotherapy in select patients with gastric or gastroesophageal adenocarcinoma and select patients with biliary tract cancer.

Treatment with 177Lu-PNT2002 resulted in a significant improvement in radiographic progression-free survival vs abiraterone acetate or enzalutamide in patients with metastatic castration-resistant prostate cancer whose disease had progressed on an androgen receptor pathway inhibitor.

Dostarlimab plus carboplatin and paclitaxel, followed by maintenance dostarlimab and niraparib, significantly improved PFS vs placebo plus chemotherapy followed by placebo in patients with primary advanced or recurrent endometrial cancer, according to data from the phase 3 RUBY trial.