2024 FDA Drug Approvals: A Year of Strategic Approvals and Long-Awaited Treatments

Total Approvals:
The FDA approved 23 new molecular entities, 2 gene therapies, and 1 T-cell therapy in 2024, marking a decrease from the 55 new drugs approved in 202324.

Notable Approvals:

Durvalumab (Imfinzi):
Approved for adults with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy1.

Ensartinib (Ensacove):
Approved for adult patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received an ALK-inhibitor14.

Cosibelimab-ipdl (Unloxcyt):
Approved for adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation1.

Accelerated Approvals:

Zenocutuzumab-zbco (Bizengri):
Granted accelerated approval for adults with specific types of non-small cell lung cancer and pancreatic adenocarcinoma1.

Asciminib (Scemblix):
Granted accelerated approval for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP)1.

Rare Disease Therapies:

Sotatercept (Winrevair):
Approved as the first activin signaling inhibitor therapy for pulmonary arterial hypertension (PAH)2.

Lisocabtagene maraleucel (Breyanzi):
Approved for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor (BTKi)14.

Study Findings:

A study found that only 43% of drugs granted accelerated approval by the FDA demonstrated clinical benefit in terms of overall survival or quality of life within 5 years of confirmatory trials5.

Sources:

1. https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancerhematologic-malignancies-approval-notifications

2. https://www.pharmamanufacturing.com/development/drug-approvals/article/55129655/notable-2024-fda-decisions

4. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2024

5. https://ascopost.com/news/april-2024/fewer-than-half-of-accelerated-approval-drugs-demonstrated-benefit-within-5-years/