FDA Updates

FoundationOne Liquid CDx can be used to identify niraparib and abiraterone acetate eligibility in patients with metastatic castration-resistant prostate cancer (mCRPC).

The designation was approved based on interim data from a phase 1 study that assessed SV-102 among males with metastatic castrate-resistant prostate cancer (mCRPC).

This is the first novel, precision mechanism of action to be released to treat patients with CIDP in over 3 decades.

Small cell lung cancer is initially responsive to platinum-based chemotherapy, but it does develop drug resistance over time, furthering the need for better treatment options.

RCT1100 is designed to deliver DNAI1 mRNA directly to affected airways through an inhaled nebulizer and fills an urgent unmet need in the treatment of those with primary ciliary dyskinesia.

Tepylute is a ready-to-dilute, injectable formula that reduces preparation time and enable dosing accuracy.

Antibody drug conjugate TUB-040 demonstrated superior biophysical properties for treating platinum-resistant ovarian cancer.

A biologics license application (BLA) for patritumab deruxtecan receives complete response letter due to inspection findings at third-party manufacturer.

After over 2 decades, the first inhaled product with a novel mechanism of action has been approved by the FDA for the treatment of chronic obtrusive pulmonary disorder.

Adagrasib receives accelerated approval for patients with previously treated KRAS G12C-mutated locally advanced or metastatic colorectal cancer (CRC).

After being previously approved in June 2023 under an Accelerated Approval process, the FDA has granted an expanded approval for non-ambulatory individuals and individuals 4 years of age or older.

Hyperhidrosis affects an estimated 10 million individuals in the US and is characterized by abnormally increased sweating, beyond what is necessary to regulate body temperature.

Although the committee's vote is non-binding, it does raise questions about optimal evaluation of psychedelics in clinical trials.

The indication is for adult patients with primary advanced or recurrent endometrial carcinoma and is the third indication that pembrolizumab has received for this disease state.

V116 (Capvaxive; Merck) elicited higher immune responses than the comparator for the serotypes that are unique to the vaccine, according to studies submitted to the FDA.

The FDA approved blinatumomab for treatment of patients with CD19-positive Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia.

Durvalumab plus carboplatin and paclitaxel, continued with durvalumab monotherapy, decreased the risk of disease progression or death by 58%.

With this approval, Yimmugo is the first approved product from the Biotest Next Level production facility.

Repotrectinib has also shown significant efficacy in ROS1 fusion-positive non¬–small cell lung cancer (NSCLC), which was also studied in the TRIDENT-1 trial.

The autoinjector will provide another option for adults in addition to the prefilled syringe that is currently available.

The indication is for the improvement of glycemic control in pediatric patients aged 10 and older with type 2 diabetes and comes after positive results from the phase 3 T2NOW clinical trial.

Continuous glucose monitoring systems offer timely biofeedback for patients with type 2 diabetes.

Elafibranor (Iqirvo; GENFIT) is a first-in-class, once daily oral peroxisome proliferator-activated receptor for the treatment of primary biliary cholangitis.

The 4-in-1 respiratory diagnostic test is either a single nasopharyngeal or anterior nasal swab that can confirm or rule out SARS-CoV-2, influenza A virus, influenza B virus, and respiratory syncytial virus with a single test.

Polyarticular juvenile idiopathic arthritis is a form of arthritis that affects multiple joints at one time.

Osimertinib demonstrates improved progression-free survival for stage 3 epidermal growth factor receptor-mutated (EGFRm) lung cancer.

The expanded indication is for the prevention of respiratory syncytial virus-associated lower respiratory tract disease in adults aged 50 through 59 years who are at an increased risk.

The new approval increases the previous dosing for surface area treatment from 25 cm2 to up to 100 cm2.