The FDA has approved a nasal spray formulation of fentanyl (Lazanda – Archimedes) for management of breakthrough pain in adult cancer patients who are already receiving and are tolerant to opioid therapy. Fentanyl is already available in the US for intravenous, intrathecal, epidural, transdermal and oral transmucosal use.

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.

Teniposide (ten i poe' side; VM 26; Vumon - Bristol), an anticancer drug that has been under investigation in the USA for 20 years, has now been approved for use in combination induction treatment of refractory acute lymphoblastic leukemia (ALL) in children. A semisynthetic derivative of podophyllotoxin, teniposide is chemically related to etoposide (VePesid - Medical Letter, 26:48, 1984).

The FDA has approved a recombinant human papillomavirus (HPV) vaccine (Cervarix – GlaxoSmithKline) for use in girls and women 10-25 years old to prevent infection with HPV types 16 and 18, which have been associated with cervical cancer. A recombinant quadrivalent HPV vaccine (Gardasil – Merck) already on the market in the US prevents infection with HPV types 6, 11, 16 and 18.

The FDA has approved the steroid prasterone (Intrarosa – Endoceutics) for intravaginal treatment of postmenopausal women with moderate-to-severe dyspareunia due to vulvovaginal atrophy (VVA). Also called dehydroepiandrosterone (DHEA), prasterone is produced in the adrenal glands, gonads, and brain and converted intracellularly into active metabolites of estrogens and androgens. DHEA has been available over the counter for years as an oral dietary supplement claimed to benefit sexual, cardiovascular, and neuropsychiatric dysfunction.

The oral kinase inhibitor tucatinib (Tukysa – Seagen) has received accelerated approval from the FDA for use in combination with trastuzumab (Herceptin) for treatment of adults with RAS wild-type human epidermal growth factor receptor 2 (HER2)-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy regimens. Tucatinib was approved in 2020 for use in combination with trastuzumab and capecitabine (Xeloda, and generics) for treatment of adults with advanced unresectable or...

Atezolizumab (Tecentriq – Genentech), an immune checkpoint inhibitor, has been approved by the FDA for treatment of unresectable or metastatic alveolar soft part sarcoma (ASPS) in patients ≥2 years old. It was previously approved for treatment of non-small cell lung cancer, small cell lung cancer, hepatocellular cancer, and melanoma (see Table 1). Atezolizumab is the first drug to be approved in the US for treatment of ASPS. ASPS is a rare disorder that affects mostly adolescents and young adults; <1% of soft tissue sarcomas are ASPS.

Many patients ask their physicians whether they should take vitamins. Since the last Medical Letter article on this subject, more data have become available on the benefits and risks of taking vitamin supplements.

Currently available techniques for colorectal cancer screening include fecal occult-blood testing, flexible sigmoidoscopy, double contrast barium enema (DCBE) and traditional optical colonoscopy. Optical colonoscopy requires bowel cleansing and sedation, and involves some risk, but is generally accepted as the best available method for detection of lesions and offers the advantage that polyps can be removed when they are identified. A less invasive screening tool, computed tomography (CT) colonography, also known as virtual colonoscopy (VC), offers an additional option.

The FDA has approved tremelimumab-actl (Imjudo – AstraZeneca), a cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) blocking antibody, for use in combination with the programmed death-ligand 1 (PD-L1) blocking antibody durvalumab (Imfinzi) and platinum-based chemotherapy for treatment of metastatic non-small cell lung cancer (NSCLC) in adults with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumor aberrations.