December 2020, Vol 11, No 6

Healthcare and biopharmaceutical industry markets were trending positively during the immediate aftermath of the 2020 election, even before the promising news from Pfizer and Moderna regarding their COVID-19 vaccines. At the 10th Annual Summit of the Association for Value-Based Cancer Care (AVBCC) in 2020, 2 industry leaders advised that the industry reaction was likely in response to an expectation of less volatility and more predictability in healthcare in 2021 with what is likely to be divided government.

The approaches to the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma are evolving, including the sequencing of therapy and a possibly expanded role for minimal residual disease (MRD) status, said William G. Wierda, MD, PhD, Section Chief, Chronic Lymphocytic Leukemia, M.D. Anderson Cancer Center, Houston, TX, at the 2020 NCCN hematologic malignancies conference.

Cancer does not discriminate based on social status, race, income, or education, but that does not mean that it is an equal-opportunity killer. Evidence shows that overall, patients with poorer socioeconomic status also have poorer health outcomes compared with those with good socioeconomic status. The American Society of Clinical Oncology (ASCO) has recently launched a program to address the role of social determinants of health in cancer care and cancer outcomes.

Sotorasib, an investigational small-molecule inhibitor of the KRAS p.G12C mutation, demonstrated promising activity and encouraging safety in patients with advanced solid tumors, in particular those with non–small-cell lung cancer (NSCLC), in the preliminary phase 1 CodeBreaK 100 trial. The findings were presented at the 2020 virtual meeting of the European Society for Medical Oncology (ESMO) and were recently published.

VS-6766, a unique inhibitor of the RAF/MEK-signaling pathway, has shown antitumor activity in RAS/RAF mutation–positive solid tumors and in multiple myeloma, when administered on an intermittent dosing schedule, according to recently published data.

Xevinapant, an investigational antagonist of IAPs (inhibitor of apoptosis proteins), prolonged overall survival (OS) in patients with locally advanced head and neck squamous-cell carcinoma (HNSCC) when added to chemoradiotherapy, according to an updated analysis of a phase 2 clinical trial that was presented at the 2020 European Society for Medical Oncology (ESMO) congress.

On December 1, 2020, the FDA approved Gallium 68 PSMA-11 (Ga 68 PSMA-11; University of California), the first drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer. Ga 68 PSMA-11 is indicated for men with suspected metastatic prostate cancer that may be curable by surgery or by radiation, and for suspected recurrent prostate cancer based on elevated serum prostate-specific antigen (PSA) levels.

On November 25, 2020, the FDA granted accelerated approval to naxitamab-gqgk (Danyelza; Y-mAbs Therapeutics), a GD2-binding monoclonal antibody, in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of relapsed or refractory high-risk neuroblastoma in the bone or bone marrow in pediatric patients aged ≥1 year and adults who achieved a partial response, minor response, or stable disease after receiving previous therapy. The FDA granted naxitamab priority review and breakthrough therapy, orphan drug, and rare pediatric disease designations.

On September 1, 2020, the FDA approved azacitidine (Onureg; Celgene), an oral nucleoside metabolic inhibitor, for maintenance treatment of adults with acute myeloid leukemia (AML) who had first complete remission (CR) or CR with incomplete blood count recovery after intensive induction chemotherapy and who are not candidates for intensive curative therapy. The FDA granted azacitidine an orphan drug designation and used its priority review for this indication.

On December 1, 2020, the FDA accelerated the approval of a new indication for pralsetinib (Gavreto; Blueprint Medicines), a RET kinase inhibitor, for the treatment of patients aged ≥12 years with advanced or metastatic medullary thyroid cancer and RET mutation who require systemic therapy or for patients with thyroid cancer and RET fusion who require systemic therapy and whose tumor is refractory to radioactive iodine, if radioactive iodine is appropriate.