FDA News

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 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.

The FDA has approved treatment with pembrolizumab plus trastuzumab and chemotherapy for HER2+ gastric/GEJ adenocarcinoma with PD-L1 CPS of 1 or greater.

Two denosumab biosimilars have been approved by the FDA for all previously approved uses for the reference drugs in cancers and osteoporosis.

The FDA has granted PYX-201 fast track designation for treatment of recurrent or metastatic HNSCC after progression post-chemoimmunotherapy.

The FDA has accepted the resubmission of a BLA for odronextamab for the treatment of patients with relapsed/refractory follicular lymphoma.

The FDA approved tislelizumab-jsgr (Tevimbra) with platinum chemotherapy as a first-line treatment for adults with PD-L1-positive, unresectable or metastatic esophageal squamous cell carcinoma.

The FDA is conducting a priority review of nivolumab plus ipilimumab for the first-line treatment of patients with unresectable or metastatic MSI-H/dMMR colorectal cancer.

The FDA granted petosemtamab plus pembrolizumab breakthrough therapy status for PD-L1–positive recurrent/metastatic head and neck squamous cell carcinoma.

The FDA granted SIGX1094 fast track status as a treatment option for diffuse gastric cancer.

AUTX-703, a novel, oral KAT2A/B degrader, has received fast track designation for use in relapsed/refractory AML.

The FDA has given RZ-001 fast track designation for HCC after demonstrating therapeutic activity in preclinical studies.

Amezalpat has been granted FDA fast track designation as treatment for patients with hepatocellular carcinoma.

Findings from the ECHELON-3 trial supported the approval of brentuximab vedotin plus lenalidomide and rituximab for relapsed/refractory LBCL.

Serial CTRS, an AI-powered tool, has been granted FDA breakthrough device designation for classifying patients with NSCLC.