Ocriplasmin (Jetrea – ThromboGenics) was recently approved by the FDA as an intravitreal injection for treatment of symptomatic vitreomacular adhesion. It is the first drug to be approved in the US for this indication.

The FDA has approved the use of subcutaneous injections of deoxycholic acid (Kybella – Kythera/Allergan) to improve the appearance of moderate to severe convexity or fullness associated with submental fat (double chin) in adults. It is the first drug approved for this indication.

On January 3, the FDA amended its Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine (Comirnaty) to incorporate the following changes. The anti-SARS-CoV-2 antibody combinations casirivimab plus imdevimab (REGEN-COV) and bamlanivimab plus etesevimab are not active against the Omicron variant of SARS-CoV-2.

The alkylating agent lurbinectedin (Zepzelca – Jazz) has received accelerated approval from the FDA for treatment of metastatic small-cell lung cancer (SCLC) in adults with disease progression on or after platinum-based chemotherapy. Accelerated approval was based on the overall response rate and duration of response. About 13-15% of lung cancers are small-cell cancers. Most SCLCs occur in patients who are current or former smokers.

Olutasidenib (Rezlidhia – Rigel), an oral isocitrate dehydrogenase-1 (IDH1) inhibitor, has been approved by the FDA for treatment of relapsed or refractory acute myeloid leukemia (AML) in adults with a susceptible IDH1 mutation. It is the second drug that targets cancer metabolism to be approved for this indication; ivosidenib (Tibsovo) was approved in 2022.

The oral cyclin-dependent kinase (CDK) 4/6 inhibitor abemaciclib (Verzenio – Lilly) has been approved by the FDA for use in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence.1It was previously approved for the same indication, but patients were also required to have a Ki-67 score ≥20%. About 70% of all breast cancers are HR-positive and HER2-negative. Ki-67 is a...

The FDA has granted regular approval to the oral kinase inhibitor capmatinib (Tabrecta – Novartis) for treatment of metastatic non-small cell lung cancer (NSCLC) in adults whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping. MET exon 14 skipping mutations occur in 3-4% of NSCLC cases. The drug received accelerated approval for the same indication in 2020 based on initial overall response rates and duration of response.

The oral kinase inhibitor pemigatinib (Pemazyre – Incyte) has been approved by the FDA for treatment of adults with relapsed or refractory myeloid/lymphoid neoplasms (MLNs) with fibroblast growth factor receptor 1 (FGFR1) rearrangements. It is the first targeted therapy to be approved in the US for this indication. The drug received accelerated approval from the FDA in 2020 for treatment of adults with previously treated, unresectable, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or other rearrangements.

Eflornithine (Iwilfin – US WorldMeds), an oral ornithine decarboxylase inhibitor, has been approved by the FDA to reduce the risk of relapse in children and with high-risk neuroblastoma who had at least a partial response to prior multiagent, multimodality therapy, including anti-GD2 immunotherapy. About 40-50% of neuroblastoma cases are classified as high-risk and they account for ~15% of all pediatric cancer deaths. Eflornithine is the first drug to be approved to reduce the risk of relapse in children with high-risk neuroblastoma. Eflornithine was previously available in the US...

Cosibelimab (Unloxcyt – Checkpoint Therapeutics), a programmed death ligand-1 (PD-L1) blocking antibody, has been approved by the FDA for treatment of locally advanced or metastatic cutaneous squamous cell carcinoma in adults who are not candidates for curative surgery or radiation. It is the first PD-L1 inhibitor to be approved in the US for this indication. The PD-1 inhibitors pembrolizumab (Keytruda) and cemiplimab (Libtayo) are also approved for treatment of cutaneous squamous cell carcinoma.