Nadofaragene firadenovec-vncg (Adstiladrin – Ferring), an adenoviral vector-based gene therapy, has been approved by the FDA for treatment of adults with high-risk Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ with or without papillary tumors. It is the first adenoviral vector-based gene therapy to be approved in the US for this indication. The immune checkpoint inhibitor pembrolizumab (Keytruda) was approved for the same indication in 2021.

Patients with lung cancer may be asking their physicians about gefitinib (ge fi' tye nib; ZD1839; Iressa -- AstraZeneca), because it has been the subject of positive coverage in the media. An inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase, this oral drug has not been approved by the FDA, but is in clinical trials in the US for treatment of non-small cell lung cancer (NSCLC) and some other solid tumors. Iressa was recently approved in Japan, and is available from the manufacturer on a "compassionate-use" basis in the US (800-236-9933).

Aprepitant (Emend - Merck), the first substance P/neurokinin 1 (NK₁) receptor antagonist to be approved by the FDA, is now available for oral use with corticosteroids and selective serotonin (5-HT₃) receptor antagonists to prevent nausea and vomiting caused by highly emetogenic anticancer drugs such as cisplatin.

Fam-trastuzumab deruxtecan-nxki (Enhertu – Daiichi Sankyo/AstraZeneca), which received accelerated approval by the FDA in 2019 for treatment of HER2-positive breast cancer based on its rate and duration of response,1 has been granted regular approval for treatment of adults with unresectable or metastatic HER2-positive breast cancer who received a prior anti-HER2-based regimen in the metastatic setting or in the neoadjuvant or adjuvant setting and developed recurrence during or within 6 months of completing treatment.

The oral kinase inhibitors selpercatinib (Retevmo – Lilly) and pralsetinib (Gavreto – Blueprint Medicines/Genentech) have been approved by the FDA for treatment of advanced or metastatic RET-mutant or RET fusion-positive cancers. They are the first drugs to be approved specifically for certain RET-driven cancers. Both drugs were granted accelerated approval based on overall response rates and the duration of response.

The oral poly(ADP-ribose) polymerase (PARP) inhibitor olaparib (Lynparza – AstraZeneca) has now been approved by the FDA for use in combination with abiraterone (Zytiga, and others) and either prednisone or prednisolone for treatment of adults with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Olaparib was previously approved by the FDA for treatment of adults with deleterious or suspected deleterious germline or somatic homologous recombinant repair (HRR) genemutated mCRPC who progressed on prior treatment with...

The FDA has approved abemaciclib (Verzenio – Lilly), an oral cyclin-dependent kinase (CDK) 4/6 inhibitor, for treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. Abemaciclib is the third CDK 4/6 inhibitor to be approved in the US for this indication.

Ado-trastuzumab emtansine (Kadcyla – Genentech), a human epidermal growth factor receptor 2 (HER2)-targeted antibody and microtubule inhibitor conjugate, has been approved by the FDA for intravenous (IV) treatment of HER2-positive metastatic breast cancer in patients previously treated with trastuzumab (Herceptin) and a taxane. The prefix was added to the new conjugate’s name at the request of the FDA to distinguish it from trastuzumab.

The immune checkpoint inhibitor dostarlimab-gxly (Jemperli – GSK) has been approved by the FDA for use in combination with carboplatin and paclitaxel for treatment of adults with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer. Dostarlimab was recently granted regular approval for treatment of adults with dMMR recurrent or advanced endometrial cancer that progressed on or following a prior platinum-containing regimen in any setting and who are not candidates for curative surgery or radiation.

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...