Articles

On November 14, 2022, the FDA accelerated the approval of mirvetuximab soravtansine-gynx (Elahere; ImmunoGen), an intravenous folate receptor alpha (FRα)-directed antibody and microtubule inhibitor conjugate, for the treatment of adults with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after 1 to 3 previous systemic treatments, regardless of previous use of bevacizumab (Avastin). Patients should be identified for treatment with mirvetuximab soravtansine by an FDA-approved test.

On October 25, 2022, the FDA accelerated the approval of teclistamab-cqyv (Tecvayli; Janssen Biotech), the first bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for the treatment of adults with relapsed or refractory multiple myeloma who received ≥4 previous lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody. The FDA granted teclistamab breakthrough therapy and orphan drug designations.

On October 21, 2022, the FDA approved tremelimumab (Imjudo; AstraZeneca), a CTLA-4 monoclonal antibody, in combination with durvalumab (Imfinzi; AstraZeneca), a PD-L1 inhibitor, for the treatment of adults with unresectable hepatocellular carcinoma (HCC). The FDA granted tremelimumab an orphan drug designation for this indication.

Two weeks after the initial approval of tremelimumab (Imjudo; AstraZeneca), a CTLA-4 monoclonal antibody, on November 10, 2022, the FDA approved this new immunotherapy, in combination with the PD-L1 inhibitor durvalumab (Imfinzi; AstraZeneca) and platinum-based chemotherapy, for the treatment of adults with metastatic non–small-cell lung cancer (NSCLC) and no EGFR or ALK genomic alterations.

On November 10, 2022, the FDA approved brentuximab vedotin (Adcetris; Seagen) in combination with a chemotherapy regimen of doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide (AVEPC) for treatment-naïve pediatric patients aged ≥2 years with high-risk classical Hodgkin lymphoma. This is the first indication for brentuximab vedotin for pediatric patients. Brentuximab vedotin has an orphan drug designation for Hodgkin lymphoma.

Results from a new study found that radiation oncologists tend to discuss sexual side effects in women undergoing treatment for cervical cancer far less frequently than they discuss sexual side effects in men undergoing treatment for prostate cancer. These findings were presented at the American Society for Radiation Oncology (ASTRO) Annual Meeting 2022 by the study’s lead investigator Jamie Takayesu, MD, Radiation Oncology Resident, University of Michigan Rogel Cancer Center, Ann Arbor.

The treatment of acute myeloid leukemia (AML) has entered a new era, with the use of more potent therapies, such as targeted agents and venetoclax (Venclexta). The advent of these newer therapies raises important issues that are yet to be clarified, said Daniel A. Pollyea, MD, MS, Clinical Director, Leukemia Services; Robert H Allen, MD Chair in Hematology Research; and Professor, Hematology, University of Colorado Blood Disorders and Cell Therapies Center, Anschutz, during a session on evolving concepts and management strategies for AML at the National Comprehensive Cancer Network (NCCN) 2022 Annual Congress: Hematologic Malignancies.

A survey of US physicians who prescribe biologics to their patients revealed that 92% were confident in the safety and efficacy of biosimilars, 89% would prescribe a biosimilar to a new patient, and 80% were comfortable initiating the switching of patients who are stable on their current biologic medication to a biosimilar. However, the majority of respondents indicated that they were not comfortable with third-party substitution for nonmedical reasons, and felt that they, along with their patients, should have control over treatment choice. Results of this survey were discussed by Ralph McKibbin, MD, FACP, FACG, AGAF, Chairman of the Alliance for Safe Biologic Medicines, in a poster presentation during the Drug Information Association 2022 Global Annual Meeting.

We review the latest clinical evidence from the phase 3 ICARIA-MM and IKEMA studies of isatuximab, an anti-CD38 mAb, in patients with RRMM. In addition, the cost implications of MM management and evolving approaches for mitigating the cost burden without compromising clinical outcomes for patients with MM are discussed.