FDA News

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The accelerated approval of infigratinib has been withdrawn by the FDA for previously treated, FGFR2-positive, advanced cholangiocarcinoma.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

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.

Trastuzumab-strf was approved for HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or GEJ adenocarcinoma.

The FDA approved tovorafenib for certain patients with relapsed or refractory pediatric low-grade glioma.

Lutetium Lu 177 dotatate was approved by the FDA for children aged 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors.

Nogapendekin alfa inbakicept-pmln has been approved for use with BCG for the treatment of BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors.

All patients treated with CAR T-cell products are recommended to be monitored life-long for the risk of secondary malignancy, according to the FDA.

Fast track designation has been granted by the FDA to PT217 for extensive stage small cell lung cancer with disease progression.

Alectinib was approved for the treatment of patients with ALK-positive non-small cell lung cancer after surgical resection.

The optical imaging agent Lumisight and the Lumicell Direct Visualization System received approval from the FDA for fluorescence imaging in breast cancer.

The FDA granted tamibarotene plus azacitidine and venetoclax fast track designation for the treatment of newly diagnosed, unfit, RARA-overexpressed AML.

The FDA’s Oncologic Drugs Advisory Committee voted in favor of minimal residual disease as an end point to support accelerated approval of multiple myeloma treatments.

Cilta-cel (ciltacabtagene autoleucel; Carvykti) was approved by the FDA to treat patients with relapsed or refractory multiple myeloma who have previously received at least one line of therapy.

The FDA granted LSTA1 rare pediatric disease designation for the treatment of osteosarcoma.