October 2021, Vol 12, No 5

Cancer remains the leading cause of death in individuals aged <80 years in the United States, and was responsible for nearly 10 million deaths worldwide in 2020.1,2 According to the National Cancer Institute, the 5-year survival rate for individuals diagnosed with localized cancer of any type is 89%.3 However, this rate drops to only 21% for those diagnosed with metastatic disease,3 highlighting the detrimental impact of late-stage diagnosis on patient outcomes.

Oropharyngeal cancer, which can develop at the base of the tongue, tonsils, and the middle part of the throat, is primarily caused by human papillomavirus (HPV) infection, the most common sexually transmitted virus and infection in the United States. Over the past 2 decades, cases of HPV-positive oropharyngeal squamous-cell carcinoma (OPSCC) have been increasing at an alarming rate among men in the United States. According to the American Cancer Society, approximately 54,000 cases of oropharyngeal and oral cavity cancer will be diagnosed in the United States in 2021, and more than 10,000 individuals will die from the disease. OPSCC is often diagnosed at an advanced stage, resulting in increased mortality and morbidity.

On September 15, 2021, the FDA accelerated the approval of mobocertinib (Exkivity; Takeda Pharmaceuticals), a tyrosine kinase inhibitor, for the treatment of adults with locally advanced or metastatic non−small-cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, as detected by the FDA-approved Oncomine Dx Target Test (Life Technologies Corporation), which was approved on the same day as a companion diagnostic for mobocertinib. The FDA granted mobocertinib priority review, breakthrough therapy designation, and orphan drug designation.

On July 16, 2021, the FDA approved belumosudil (Rezurock; Kadmon Holdings), a kinase inhibitor, for the treatment of patients aged ≥12 years with chronic graft-versus-host disease (GVHD) after failure of ≥2 previous lines of systemic therapy. The FDA granted belumosudil breakthrough therapy designation and priority review for this indication.

On August 31, 2021, the FDA approved zanubrutinib (Brukinsa; BeiGene), a Bruton tyrosine kinase (BTK) inhibitor, for the treatment of adults with Waldenström’s macroglobulinemia. Zanubrutinib was previously approved for the treatment of adults with mantle-cell lymphoma.

On August 25, 2021, the FDA approved ivosidenib (Tibsovo; Servier Pharmaceuticals), an oral IDH1 inhibitor, for the treatment of adults with previously treated, locally advanced or metastatic cholangiocarcinoma (CCA) and an IDH1 mutation, as detected by an FDA-approved test. The FDA granted ivosidenib a priority review for this indication and an orphan drug designation.

On August 10, 2021, the FDA approved the combination of lenvatinib (Lenvima; Eisai) plus pembrolizumab (Keytruda; Merck) for the first-line treatment of adults with advanced renal-cell carcinoma (RCC). The FDA granted this combination a priority review and breakthrough therapy designation.

On July 26, 2021, the FDA accelerated the approval of a new indication for the PD-1 inhibitor pembrolizumab (Keytruda; Merck) for the treatment of patients with high-risk, early-stage, triple-negative breast cancer (TNBC) in combination with chemotherapy as a neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.