News

The FDA has accepted a supplemental New Drug Application for lorlatinib as a first-line treatment of patients with ALK-positive metastatic non–small cell lung cancer and has granted the sNDA a Priority Review.

Here is a look back at the FDA happenings from the month of December 2020.

Neal Shore, MD, discusses the current outlook for the treatment landscape in advanced or metastatic urothelial carcinoma.

In an interview with Targeted Oncology, Ira Winer, MD, PhD, discussed the findings from the ARTISTRY-1 and ARTISTRY-2 studies, exploring the safety and efficacy of ALKS 4230 as treatment of patients with gynecologic cancers as well as other solid tumors.

When patients with myelofibrosis who required hematopoietic stem cell transplant received a conditioning regimen of thiotepa, busulfan, and fludarabine along with 2 two alkylating agents, the subsequent transplants were nearly all successful.

In an interview with Targeted Oncology, Rajat Bannerji, MD, PhD, discussed the early and encouraging findings from a novel bispecific antibody for the treatment of patients with follicular lymphoma and diffuse large B-cell lymphoma.

Thomas C. Krivak, MD, interpreted the results clinical trials of bevacizumab as treatment of patients with ovarian cancer to determine the optimal treatment strategy for a 69-year-old patient.

The United States House of Representatives introduced the Multi-Cancer Early Detection Screening Coverage Act, which would give Medicare beneficiaries access to innovative multi-cancer screening technology by guaranteeing timely Medicare coverage of these tests.

Experts in oncology and hematology review some of the most impactful FDA approvals from 2020 in lung, breast, blood, gastrointestinal, and genitourinary cancers.

Biological activity was observed with dusquetide as treatment of severe oral mucositis in patients with head and neck cancer receiving chemoradiation in the pivotal phase 3 DOM-INNATE study.

The FDA updated the prescribing label for the approval of ibrutinib to include efficacy and safety data as combination therapy with rituximab as treatment of patients with Waldenström’s macroglobulinemia.

The novel CD123-targeting antibody-drug conjugate IMGN632 demonstrated promising clinical activity in a cohort of heavily pretreated patients with relapsed/refractory blastic plasmacytoid dendritic cell neoplasm and had a favorable tolerability.

In patients with bacillus Calmette-Guérin unresponsive non-muscle invasive bladder cancerwith high-risk carcinoma in situ disease, the combination of intravesical BCG and N-803 demonstrated efficacy with a tolerable safety profile, according to findings from the pivotal phase 2/3 QUILT 3.032 study.

Encouraging early data were observed with galinpepimut-S in combination with immune checkpoint inhibitors as treatment of patients with 2 different solid tumor types who had exhausted standard therapeutic options.

Cabozantinib demonstrated significant improvement in progression-free survival in patients with radioiodine-refractory differentiated thyroid cancer who have progressed after up to 2 prior vascular endothelial growth factor receptor-targeted therapies compared with placebo, meeting the primary end point of the pivotal phase 3 COSMIC-311 clinical trial.

A new multi-analyte prognostic assay has demonstrated the potential to risk-stratifying patients with mantle cell lymphoma based on the particular molecular signature of an individual patient’s cancer, according to a new study.

A review by an Independent Data Monitoring Committee determined that combination of gilteritinib plus azacitidine would not likely improve overall survival compared with azacitidine alone in patients newly diagnosed FLT3-positive acute myeloid leukemia who were ineligible for intensive induction chemotherapy, missing the primary end point of the phase 3 LACEWING clinical trial.

Treatment with rucaparib led to an improvement in investigator-assessed progression-free survival compared with chemotherapy in patients with relapsed ovarian cancer with a BRCA mutation who have received 2 or more prior lines of chemotherapy, meeting the primary end point of the phase 3 ARIEL4 clinical trial.

Patients with relapsed or refractory mantle cell lymphoma treated with a daily dose of parsaclisib demonstrated significant activity and tolerability for the next-generation PI3Kδ inhibitor, according to findings from the phase 2 CITADEL-205 trial.

The submission of a Biologics License Application has been initiated seeking approval of JZP-458 as a part of a multi-agent chemotherapy regimen as treatment of adult and pediatric patients with acute lymphoblastic leukemia or lymphoblastic lymphoma who developed hypersensitivity or silent inactivation to E. coli-derived asparaginases.

Rolling submission has been initiated for a Biologics License Application, submitting data to the FDA for the potential approval of ciltacabtagene autoleucel for the treatment of adult patients with relapsed and/or refractory multiple myeloma.

The Association of Community Cancer Centers urged the Centers for Medicare and Medicaid Services to withdraw from The Most Favored Nation Model Interim Final Rule with Comment Period due to fears of the disproportionate impact the model could have on cancer care.

The FDA has issued an emergency use authorization for a second vaccine, the mRNA-1273 Moderna COVID-19 Vaccine, for the prevention of coronavirus disease 2019 (COVID-19) in individuals 18 years of age and older.

The FDA has approved osimertinib as an adjuvant therapy for patients with non–small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test, for use following tumor resection.

The FDA has approved selinexor in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least 1 prior therapy.

The FDA has granted approval to oral relugolix as treatment of patients with advanced prostate cancer.

The FDA granted approval to rituximab-arrx, a biosimilar to rituximab as treatment of adult patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis.

A New Drug Application was submitted to the FDA seeking approval of the investigational KRAS G12C inhibitor sotorasib as treatment of patients with KRAS G12C-mutated locally advanced or metastatic non–small cell lung cancer, as determined by an FDA-approved test, following at least 1 prior systemic therapy.

The FDA granted a Priority Review designation to pembrolizumab for potential approval with platinum and fluoropyrimidine-based chemotherapy as frontline treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus and gastroesophageal junction.

Pembrolizumab plus lenvatinib induced a statistically significant and clinically meaningful improvement in overall survival, progression-free survival, and objective response rate compared with chemotherapy in patients with advanced endometrial cancer after prior systemic therapy in the phase 3 KEYNOTE-775/Study 309 trial.