The FDA has granted regular approval to dostarlimabgxly (Jemperli – GSK), an immune checkpoint inhibitor, for treatment of adults with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer that has progressed on or following a prior platinum-containing regimen in any setting and who are not candidates for curative surgery or radiation. Dostarlimab received accelerated approval in 2021 for treatment of adults with dMMR recurrent or advanced endometrial cancer or nonendometrial solid tumors that progressed on or following prior treatment and who have no...

The oral kinase inhibitor futibatinib (Lytgobi – Taiho) has received accelerated approval from the FDA for treatment of adults with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma with fibroblast growth factor receptor 2 (FGFR2) fusions or other rearrangements. Accelerated approval was based on the overall response rate and duration of response. Futibatinib is the second drug to be approved for this indication; pemigatinib (Pemazyre) was approved earlier.

Polatuzumab vedotin-piiq (Polivy – Genentech), a CD79b-directed antibody and microtubule inhibitor conjugate, has been approved by the FDA for use in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) for first-line treatment of diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), or high-grade B-cell lymphoma (HGBL) in adults who have an International Prognostic Index (IPI) score ≥2. The drug was previously approved for use in combination with bendamustine and rituximab for treatment of patients with relapsed or refactory DLBCL,...

Asciminib (Scemblix – Novartis), an oral kinase inhibitor, has been approved by the FDA for treatment of adults with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP) previously treated with ≥2 tyrosine kinase inhibitors and for adults with Ph+ CML in CP with a T315I mutation.

Elranatamab-bcmm (Elrexfio – Pfizer), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, has been granted accelerated approval by the FDA for treatment of relapsed or refractory multiple myeloma in adults who received ≥4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. Accelerated approval was based on the response rate and durability of response. Elranatamab is the second bispecific BCMA-directed CD3 T-cell engager to be approved for this indication; teclistamab (Tecvayli) was the...

The FDA has granted regular approval to the oral kinase inhibitor tepotinib (Tepmetko – EMD Serono) for treatment of adults with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. MET exon 14 skipping mutations occur in 3-4% of NSCLC cases and are associated with advanced disease and a poor prognosis. Tepotinib received accelerated approval for the same indication in 2021 based on initial overall response rates and duration of response.

View the Table: GLP-1 and GIP/GLP-1 Receptor Agonists for Type 2 Diabetes

Lazertinib (Lazcluze – Janssen Biotech), an oral kinase inhibitor, has been approved by the FDA for use in combination with the EGFR-MET bispecific antibody amivantamab (Rybrevant) for first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations. This is the first approval for Lazcluze; amivantamab was previously approved for use alone and in combination with carboplatin and pemetrexed for treatment of NSCLC with EGFR exon 20 insertion...

Revumenib (Revuforj – Syndax), an oral menin inhibitor, has been approved by the FDA for treatment of relapsed or refractory acute leukemia in patients ≥1 year old with a lysine methyltransferase 2A gene (KMT2A) translocation. It is the first menin inhibitor to be approved in the US.

Mirdametinib (Gomekli – SpringWorks Therapeutics), an oral kinase inhibitor, has been approved by the FDA for treatment of neurofibromatosis type 1 (NF1) in patients ≥2 years old who have symptomatic plexiform neurofibromas not amenable to complete resection. Mirdametinib is the second drug to be approved for this indication in the US and the first to be approved for use in adults. The oral kinase inhibitor selumetinib (Koselugo) was approved in 2020 for use in patients 2-17 years old.