Mirvetuximab soravtansine-gynx (Elahere – Immuno-Gen), an antibody-drug conjugate, has received accelerated approval by the FDA for treatment of folate receptor (FR) alpha-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer in adults who received 1-3 prior lines of systemic therapy. Accelerated approval was based on the overall response rate and median duration of response.

The FDA has approved lutetium lu 177 vipivotide tetraxetan (Pluvicto – Novartis) for treatment of prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) in adults previously treated with androgen receptor (AR) pathway inhibitors and taxane-based chemotherapy.

The FDA has approved margetuximab-cmkb (Margenza – MacroGenics), a HER2/neu receptor antagonist, for use in combination with chemotherapy for treatment of metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer in adults who received ≥2 prior anti-HER2 regimens, at least one of which was for metastatic disease.

Mobocertinib (Exkivity – Takeda), an oral kinase inhibitor, has received accelerated approval from the FDA for treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations in adults whose disease has progressed on or after platinum-based chemotherapy. Accelerated approval was based on the overall response rate and duration of response. Mobocertinib is the second drug to become available in the US for this indication; the IV EGFR-MET bispecific antibody amivantamab (Rybrevant) was approved...

Amivantamab-vmjw (Rybrevant – Janssen), an EGFR-MET bispecific antibody, has received accelerated approval from the FDA for IV treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations in adults whose disease has progressed on or after platinum-based chemotherapy. It is the first bispecific antibody to become available in the US for this indication. Accelerated approval of the drug was based on the overall response rate and duration of response.

The oral kinase inhibitor alpelisib (Vijoice – Novartis) has been approved by the FDA for treatment of patients ≥2 years old with severe manifestations of PIK3CA-related overgrowth spectrum (PROS) who require systemic treatment. Alpelisib is the first drug to be approved in the US for this indication. It was also approved in 2019 as Piqray for use in combination with fulvestrant for treatment of certain types of breast cancer.

The FDA has approved ciltacabtagene autoleucel (Carvykti – Janssen), a B-cell maturation antigen (BCMA)-directed genetically-modified cellular product, 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. Carvykti is an individualized cellular product prepared from the patient's own T cells, which are genetically modified to express chimeric antigen receptors (CAR) and then infused back into the patient. Idecabtagene...

The oral tyrosine kinase inhibitor neratinib (Nerlynx – Puma Biotechnology) has been approved by the FDA for use in combination with capecitabine (Xeloda, and generics) for treatment of advanced or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer in adults who received ≥2 prior anti-HER2-based regimens for metastatic disease. It was previously approved for use as monotherapy for extended adjuvant treatment of adults with early-stage, HER2-positive breast cancer following adjuvant trastuzumab (Herceptin)-based therapy. HER2 is overexpressed in...

Teclistamab-cqyv (Tecvayli – Janssen), 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 response rate. Teclistamab is the first bispecific BCMA-directed CD3 T-cell engager to be approved in the US.

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.