Articles

On May 28, 2021, the FDA accelerated the approval of sotorasib (Lumakras; Amgen), an oral KRAS inhibitor of the RAS GTPase family, for the treatment of adults with locally advanced or metastatic non–small-cell lung cancer (NSCLC) associated with KRAS G12C mutation, as determined by an FDA-approved test, after ≥1 systemic therapies. The FDA granted sotorasib orphan drug and breakthrough therapy designations.

On May 21, 2021, the FDA accelerated the approval of amivantamab-vmjw (Rybrevant; Janssen/Johnson & Johnson), a bispecific antibody targeting mutations in the EGFR and MET pathways, for adults with non–small-cell lung cancer (NSCLC) that is associated with EGFR exon 20 insertion mutations, as detected by the FDA-approved Guardant360 CDx test, which was approved on the same day as a companion diagnostic for amivantamab. The FDA had granted amivantamab a breakthrough therapy designation for this indication.

On April 23, 2021, the FDA accelerated the approval of loncastuximab tesirine-lpyl (Zynlonta; ADC Therapeutics SA), an intravenous, CD19-directed antibody and alkylating agent conjugate, for the treatment of relapsed or refractory large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma, in adults who have received ≥2 lines of systemic therapy.

On May 5, 2021, the FDA accelerated the approval of the PD-1 inhibitor pembrolizumab (Keytruda; Merck & Co), in combination with trastuzumab plus fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.

On April 16, 2021, the FDA approved the PD-1 inhibitor nivolumab (Opdivo; Bristol Myers Squibb), in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, or esophageal adenocarcinoma. Nivolumab was the first immunotherapy approved by the FDA for first-line treatment of gastric cancer.

Selpercatinib (Retevmo) demonstrated antitumor activity in RET fusion–positive tumors other than lung cancer and thyroid cancer, according to interim results from the phase 1/2 LIBRETTO-001 clinical trial. Results from the trial were presented by Vivek Subbiah, MD, Medical Director, Clinical Center for Targeted Therapy, The University of Texas M.D. Anderson Cancer Center, Houston, at the 2021 virtual American Association for Cancer Research annual meeting.

Results of the SWOG S1007 RxPONDER clinical trial suggest that many postmenopausal women with early-stage hormone receptor (HR)-positive, HER2-negative breast cancer, and 1 to 3 positive axillary lymph nodes may be able to avoid adjuvant chemotherapy. By contrast, premenopausal women can derive benefit from adjuvant chemotherapy, based on findings of a prespecified interim analysis of the phase 3 RxPONDER clinical trial; the findings were presented at the 2020 San Antonio Breast Cancer Symposium.

On January 15, 2021, experts in the management of patients with cholangiocarcinoma (CCA) convened for a virtual accredited continuing education satellite symposium held during the 2021 annual meeting of the American Society of Clinical Oncology Gastrointestinal Cancers Symposium. The goal was to educate healthcare providers on various aspects of CCA, including epidemiology, current standards of care, unmet clinical needs, the safety and efficacy of fibroblast growth factor receptor (FGFR) inhibitors as second-line therapy, and practical approaches to incorporating FGFR inhibitors into the treatment paradigm for the disease.

According to the American Cancer Society, nearly 35,000 new patients with multiple myeloma are diagnosed annually in the United States, with more than 12,000 deaths attributed to this cancer. However, with the introduction of several novel therapies, the outcomes for patients with newly diagnosed multiple myeloma have improved substantially over the past decade.

Researchers have identified 2 inherited pathogenic genetic variants in patients with pediatric neuroblastoma, according to results from a study presented at the 2021 virtual American Association for Cancer Research annual meeting. Both variants—the ALK gene and loss of function in PHOX2B—are associated with worse outcomes.