FDA News

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.

The FDA has granted breakthrough device designation to the ACR-368 OncoSignature assay for use in endometrial cancer.

After a phase 3 study showed a promising pCR rate with HLX11, the pertuzumab biosimilar’s BLA has been accepted for review by the FDA.

The FDA has approved a companion diagnostic to determine if patients with HR-positive, HER2-ultralow metastatic breast cancer are eligible for T-DXd treatment.

January's FDA oncology approvals offer new treatment options for breast cancer, mantle cell lymphoma, and other malignancies.

T-DXd has received FDA approval for the treatment of unresectable or metastatic HR+, HER2-low/-ultralow breast cancer in patients whose disease progressed on prior endocrine therapy in the metastatic setting.

Treosulfan plus fludarabine was approved by the FDA for children and adults with AML or MDS before allogenic hematopoietic stem cell transplantation.

Datopotamab deruxtecan-dlnk received approval from the FDA for previously treated unresectable or metastatic, HR-positive, HER2-negative breast cancer.

The FDA has approved sotorasib with panitumumab for adult patients with KRAS G12C-mutated metastatic colorectal cancer (mCRC) whose disease progressed after chemotherapy.

The FDA approved acalabrutinib in combination with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma who are ineligible for autologous stem cell transplant.

GSK5764227 has been granted FDA breakthrough therapy designation, potentially expediting its development as a treatment for relapsed/refractory osteosarcoma.

The FDA has released draft guidance with recommendations on tissue biopsies in clinical trials for adults and children.