FDA News

The FDA approved a perioperative pembrolizumab regimen in head and neck squamous cell carcinoma, marking the first approval in this cancer type in 6 years.

An oral tablet formulation of zanubrutinib was approved for use in patients with certain lymphomas or leukemia and Waldenström macroglobulinemia.

UGN-102 has received FDA approval for use in patients with low-grade intermediate-risk non-muscle-invasive bladder cancer.

The tyrosine kinase inhibitor taletrectinib has been approved for use in patients with ROS1-positive non-small cell lung cancer.

The FDA approved the first oral treatments for paraganglioma, pheochromocytoma, and anal cancer in May.

The FDA approved darolutamide monotherapy for use in metastatic hormone-sensitive prostate cancer following ARANOTE findings.

The novel antibody-drug conjugate EBC-129 has been fast tracked by the FDA for approval in pancreatic ductal adenocarcinoma.

The oral TKI sevabertinib has been granted priority review for use in patients harboring HER2 mutations in non-small cell lung cancer.

Retifanlimab has received approval for the frontline treatment of advanced anal cancer from the FDA.

Belzutifan has become the first FDA-approved oral therapy for pheochromocytoma or paraganglioma.

ADRX-0706 has received FDA fast track designation for the treatment of metastatic or locally advanced squamous cell cervical cancer.

The safety and efficacy of givinostat is being assessed vs hydroxyurea in the phase 3 GIV-IN PV trial.

The FDA has granted accelerated approval to avutometinib and defactinib in KRAS-mutated recurrent low-grade serous ovarian cancer.

The FDA granted a complete response letter with no safety concerns for the new drug application for TLX101-CDx’s use in glioma imaging.

Approvals in oncology during April included treatments for breast cancer, colorectal cancer, and more.

The selective CDK2 inhibitor INX-315 has been given FDA fast track designation for use in CCNE1-amplified, platinum-resistant ovarian cancer.

A ready-to-dilute formulation of thiotepa has been approved by the FDA for use in breast and ovarian cancers.

The FDA approved penpulimab-kcqx combination and monotherapy for non-keratinizing nasopharyngeal carcinoma.

The FDA has granted approval to nivolumab plus ipilimumab for use in unresectable or metastatic hepatocellular carcinoma.

The FDA approved bevacizumab-nwgd across several gastrointestinal, gynecological, brain, and lung cancer types.

The FDA approved larotrectinib for use in adult and pediatric patients with NTRK fusion-positive solid tumors with few other options.

The accelerated approval for nivolumab monotherapy in unresectable/metastatic MSI-H/dMMR CRC has also been converted to regular approval.

The FDA approved treatments in various gastrointestinal and genitourinary cancers in March.

The complete response letter, issued by the FDA, does not identify what deficiencies regulators found in camrelizumab/rivoceranib for advanced HCC.

The FDA has approved neoadjuvant durvalumab plus chemotherapy followed by adjuvant durvalumab after radical cystectomy in MIBC.

Indications for 177Lu-PSMA-617 now include taxane-based chemotherapy naive adults with PSMA+ mCRPC.

The FDA approved cabozantinib for use in patients with previously treated unresectable, locally advanced or metastatic, well-differentiated epNETs or pNETs.

TLX007-CDx was approved by the FDA for PSMA-PET scanning in adult male patients with prostate cancer with suspected metastasis or suspected recurrence.