Caroline Seymour

The FDA has approved a label expansion for ibrutinib with an oral suspension formulation in all current indications.

Rusfertide displayed activity in phlebotomy-dependent polycythemia vera.

The FDA has determined that sufficient criteria have been met to withdraw the approval for melphalan flufenamide in patients with multiple myeloma.

A BLA seeking the approval of datopotamab deruxtecan in pretreated nonsquamous non–small cell lung cancer is under review by the FDA.

Investigation of RVT-2001 will be discontinued following an insufficient display of benefit in patients with myelodysplastic syndrome.

BXCL701 has been granted fast track designation for select patients with metastatic small cell neuroendocrine prostate cancer by the FDA.

R. Lor Randall, MD, FACS, explains the next steps in ensuring adherence to clinical care guidelines in extremity sarcoma.

Apalutamide plus androgen deprivation therapy improved prostate-specific antigen progression-free survival in castration-sensitive prostate cancer.

Belantamab mafodotin plus bortezomib and dexamethasone improved PFS vs daratumumab plus bortezomib and dexamethasone in relapsed/refractory myeloma.

FDA grants fast-track status to BNT325/DB-1305 for patients with platinum-resistant ovarian epithelial, fallopian tube, or primary peritoneal cancer.

The EMA has accepted for review an MAA seeking the approval of linvoseltamab for use in select patients with relapsed/refractory multiple myeloma.

The FDA has granted a fast track designation to the T-cell therapy BST02 for the treatment of patients with all forms of liver cancer.

VDA-1102 led to an objective response rate of 56% in patients with mycosis fungoides, according to findings from an interim analysis of a phase 2a study.

Enfortumab vedotin plus pembrolizumab showed consistent overall survival and progression-free survival benefit in all patients enrolled in EV-302.

NICE has recommended talazoparib for the treatment of patients with advanced or metastatic HER2-negative breast cancer with germline BRCA1/2 mutations.

PFS was significantly improved with durvalumab plus bevacizumab and TACE vs TACE alone in patients with unresectable HCC eligible for embolization.

The FDA has granted an orphan drug designation to PTX-252 for the treatment of patients with acute myeloid leukemia.

Treatment with THIO followed by cemiplimab-rwlc led to a high DCR regardless of dose level in patients with pretreated non–small cell lung cancer.

Treatment with TLD-1433 led to 6-, 12-, and 15-month CR rates of 54%, 38%, and 37%, respectively, in patients with non–muscle invasive bladder cancer.

Tamibarotene plus venetoclax/azacitidine elicited higher responses rates vs venetoclax/azacitidine in RARA-overexpressed acute myeloid leukemia.

The European Commission granted marketing authorization for SC atezolizumab co-formulated with Enhanze for all approved indications of IV atezolizumab.

Treatment with JBI-802, the first-in-class CoREST inhibitor with dual LSD1 and HDAC6 activity was shown to be safe and active.

The FDA has granted fast-track status to RC88 for use in patients with platinum-resistant recurrent epithelial ovarian cancer.

The FDA has accepted the filing of an ANDA for Lutetium Lu 177 Dotatate indicated for patients with gastroenteropancreatic neuroendocrine tumors.

The FDA has issued a CRL to the zolbetuximab BLA for patients with HER2- gastric or GEJ junction adenocarcinoma whose tumors are Claudin18.2 positive.

Significant tumor necrosis greater than 70% occurred in 3 patients with resectable hepatocellular carcinoma following neoadjuvant treatment with low-dose stereotactic body radiation therapy and cemiplimab-rwlc and adjuvant cemiplimab.

A biologics license application seeking the approval of the investigational positron emission tomography imaging agent 89Zr-DFO-girentuximab in clear cell renal cell carcinoma has been submitted to the FDA.

The phase 3 RELATIVITY-123 trial evaluating the fixed-dose combination of nivolumab and relatlimab in patients with microsatellite stable metastatic colorectal cancer will be discontinued due to futility.

David P. Carbone, MD, PhD, sought to transform lung cancer care and did it—but didn’t anticipate the personal journey it would put him on.

Findings from the EV-302 trial presented at the 2023 ESMO Congress revealed that the combination of enfortumab vedotin and pembrolizumab may become the preferred frontline standard of care for patients with locally advanced or metastatic urothelial cancer regardless of cisplatin eligibility.