FDA News

The updated risk evaluation and mitigation strategies for autologous CAR T-cell therapy removed requirements for training and educational materials about the risk for certain toxicities.

Throughout June, the FDA approved drugs for the treatment of diseases including myelodysplastic syndrome, thyroid cancer, endometrial cancer, colorectal cancer, and follicular lymphoma.

Monotherapy with IBI343 received fast track designation from the FDA for advanced unresectable or metastatic pancreatic ductal adenocarcinoma.

An sBLA was granted priority review from the FDA, which is seeking the approval of pembrolizumab plus chemotherapy for the frontline treatment of malignant pleural mesothelioma.

The ready-to-dilute formulation of Tepylute for breast and ovarian cancers can help to reduce prep time and provide more accurate dosing.

An accelerated approval has been granted by the FDA to epcoritamab-bysp (Epkinly) for adult patients with relapsed or refractory follicular lymphoma after 2 or more lines of systemic therapy.

Accelerated approval has been granted to adagrasib for use with cetuximab in previously treated adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer.

The biologics license application for subcutaneous amivantamab is seeking approval for the treatment of EGFR-positive non-small cell lung cancer.

The approval of this pembro-chemo combination for adults with primary advanced or recurrent endometrial carcinoma includes those with mismatch repair-proficient or -deficient disease.

The FDA approved durvalumab plus carboplatin and paclitaxel, followed by single-agent durvalumab for primary advanced or recurrent dMMR endometrial cancer.

The FDA granted accelerated approval to repotrectinib to treat adult and pediatric patients with NTRK gene fusion-positive solid tumors.

This traditional approval updates the accelerated approval that selpercatinib received in 2020 for this indication in patients 12 years and older.

The priority review granted by the FDA to the supplemental new drug application for osimertinib is seeking approval for its treatment of stage III non-small cell lung cancer with EGFR mutations.

The FDA granted an approval to imetelstat for certain patients with low- to intermediate-1-risk MDS who have transfusion-dependent anemia.

This marks the only CAR T-cell therapy approved by the FDA for 4 subtypes of non-Hodgkin lymphoma.

Selpercatinib was granted accelerated approval from the FDA for patients aged 2 years and older with thyroid cancer or solid tumors with RET mutations.

A breakthrough device designation has been granted by the FDA to Teal Wand, an at-home screening test for cervical cancer.

The accelerated approval of infigratinib has been withdrawn by the FDA for previously treated, FGFR2-positive, advanced cholangiocarcinoma.

The BLA for zenocutuzumab to treat NRG1-positive non–small cell lung cancer and pancreatic cancer received priority review from the FDA.

A biologics license application has been accepted by the FDA for subcutaneous nivolumab to treat adult patients eligible for approved solid tumor nivolumab indications

Tarlatamab, a bispecific T-cell engager, was approved by the FDA for adults with extensive-stage small cell lung cancer.

Lisocabtagene maraleucel was approved by the FDA to treat adults with relapsed/refractory follicular lymphoma who were treated with 2 or more prior lines of systemic therapy.

One of the first HPV self-collection solutions has been approved by the FDA, which can identify women at risk of developing cervical cancer.

Dostarlimab plus chemotherapy has been granted priority review from the FDA to expand its indication to all adult patients with primary advanced or recurrent endometrial cancer.

The FDA granted fast track designation to CTX-009 plus paclitaxel for pretreated metastatic or locally advanced biliary tract cancer.

A screening test has been approved by the FDA for adults 45 years of age or older with an average risk for developing colorectal cancer.

Throughout April, the FDA approved drugs for the treatment of diseases including solid tumors, lung cancer, multiple myeloma, bladder cancer, and low-grade glioma.

The FDA has approved tisotumab vedotin-tftv for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.