News

A new drug application has been resubmitted to the FDA for Pedmark, a sodium thiosulfate formulation, for the prevention of ototoxicity induced by cisplatin-based chemotherapy in patients under the age of 18 years old with localized, non-metastatic solid tumors.

Joshua K. Sabari, MD, discusses the need for EGFR inhibitors designed specifically to treat patients with EGFR-mutant non–small cell lung cancer and an exon 20 insertion.

The FDA has approved Guardant360, a liquid biopsy companion diagnostic for tumor mutation profiling or comprehensive genomic profiling to identify patients with locally advanced or metastatic non-small cell lung cancer who have a KRAS G12C mutation and may benefit from sotorasib.

The FDA has accepted and granted priority review to the new drug application for plinabulin in combination with granulocyte colony-stimulating factor for the prevention of chemotherapy-induced neutropenia in patients with cancer.

Here is a look back at the FDA happenings from the month of May 2021.

The FDA has granted accelerated approval to the oral FGFR1-3 selective inhibitor, infigratinib for the treatment of patients with cholangiocarcinoma who harbor an FGFR2 gene fusion or rearrangement.

Data collected and analyzed from the Surveillance, Epidemiology, and End Results Medicare database showed that elderly patients with small-cell lung cancer had a substantial burden from myelosuppression events while on chemotherapy.

The FDA has granted accelerated approval to sotorasib for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer, as determined by an FDA-approved test, who have received at least one prior systemic therapy.

Findings from the Trending Now in Cancer Care 2020 report spotlights the impact of the coronavirus 2019 pandemic, a plummet in cancer screenings, health inequities, and more.

While the volume and variety of information coming from current studies seems overwhelming, it is what is changing the cancer care environment today.

Alexey Danilov, MD, a hematologist oncologist at the City of Hope Comprehensive Cancer Center, discusses treatment options for relapsed/refractory chronic lymphocytic leukemia.

In an interview with Targeted Oncology, Deepu Madduri, MD discussed the need for further CAR T-cell therapy research, expanding it into other hematology malignancies. She also discussd management of the common adverse events associated with CAR T cells.

Melflufen flufenamide has been deemed non-inferior to pomalidomide for the treatment of relapsed/refractory (R/R) multiple myeloma.

The American Urological Association updated its guidelines on Renal Masses and Localized Renal Cancer, expanding the use of genetic counseling and updating the use of active surveillance.

In an interview with Targeted Oncology following the medical conference presentation, Ritu Salani, MD, expanded on the role biomarkers play in the treatment of cervical cancer, how this testing looks in the everyday clinics, and how it can potentially change pending competition of ongoing clinical trials.

In an interview with Targeted Oncology, Benjamin Levy, MD, discusses the importance of molecular testing in lung cancer, the efficacy and future of targeted therapies, and upcoming practice-changing trials.

The FDA has granted approval to piflufolastat F 18 injection, a prostate-specific membrane antigen–targeted positron emission tomography imaging agent, to identify patients who may have metastasis or recurrence of prostate cancer.

Rajneesh Nath, MD, discusses outcomes for older patients with acute myeloid leukemia.

Idecabtagene vicleucel is now an available treatment option for some patients with relapsed or refractory multiple myeloma who are being treated at Seattle Cancer Care Alliance.

In an interview with Targeted Oncology, Risa Wong, MD, discussed platinum versus non-platinum containing chemotherapy as a later-line treatment for metastatic urothelial carcinoma.

The investigational CDK4/6 ARK5 inhibitor, ON 123300, has been dosed in the first time in a patient whose is enrolled in a phase 1 trial of ON 123300 for the treatment of advanced cancers.

Mantle cell lymphoma cell lines with intrinsic resistance to BTK inhibitors displayed anti-tumor activity on treatment with tazemetostat as monotherapy or in combination with zanubrutinib, according to data from a preclinical analysis.

Marie E. Cabanillas, MD, an oncologic endocrinologist at the University of Texas MD Anderson Cancer Center, discusses current unmet needs in advanced or metastatic TRK fusion-Positive thyroid cancer.

The FDA has accepted the biologic license application (BLA) for ublituximab in combination with umbralisib for the treatment of patients with chronic lymphocytic leukemia and small lymphocytic lymphoma.

Deeper remissions in patients with newly diagnosed, high-risk/secondary acute myeloid leukemia may be achieved with CPX-351 treatment and lead to improvement in overall survival, according to post hoc analyses of a phase 3 study.

The combination of ibrutinib and venetoclax showed a favorable benefit-risk profile in patients with relapsed or refractory chronic lymphocytic leukemia treated in the VISION/HOVON 141.

The FDA has granted breakthrough therapy designation to the combination of VS-6766 and defactinib for the treatment of all patients with recurrent low-grade serous ovarian cancer.

A biologic license application has been submitted to the FDA for the PD-1 monoclonal antibody drug penpulimab for the third-line treatment of metastatic nasopharyngeal carcinoma.

Nadia Harbeck, MD, PhD, discusses how the monarchE trial, which evaluated the efficacy of endocrine therapy with or without abemaciclib, will change breast cancer treatment.