Nichole Tucker

A Fast Track designation was granted by the FDA to the soluble LAG-3 protein, eftilagimod alpha for the frontline treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma.

The FDA granted a regular approval to sacituzumab govitecan for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease.

The FDA has approved a higher dose of cetuximab for the treatmen of patients with KRAS wild-type, EGFR-expressing metastatic colorectal cancer or squamous cell carcinoma of the head and neck.

The FDA has issued a letter to the developer of the immunotherapy vaccine, ERC1671, recommending that the phase 2 clinical trial of ERC1671 in combination with granulocyte-macrophage colony-stimulating factor, and cyclophosphamide for the treatment of glioblastoma be terminated.

TPX-0046, a next-generation RET inhibitor demonstrated preliminary clinical activity in patients with RET-driven cancers who were treated in the phase 1/2 SWORD-1 clinical trial.

In an interview with Targeted Oncology, Thomas Hutson, DO, PharmD, reviewed findings from the CLEAR study and how these data are set to re-shape the treatment landscape of advanced renal cell carcinoma.

A proprietary noninvasive test designed to detect pancreatic cancer has been granted breakthrough device designation by the FDA for patients with new-onset diabetes.

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

The FDA has granted approval to the combination of isatuximab added to carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.

In patients with polycythemia vera, long-term use of the histone deacetylase inhibitor givinostat may be warranted after the agent demonstrated tolerable safety and good efficacy over a 4-year period in an ongoing, multicenter, open-label, single-arm study of patients with a chronic myeloproliferative neoplasm who are positive for a JAK2 V617F mutation.

The FDA has granted fast track designation to Annamycin for the treatment of soft tissue sarcoma lung metastases, according to a press release from Moleculin Biotech, Inc.

Gilteritinib showed improvement in overall survival in patients with relapsed or refractory FLT3 mutation-positive acute myeloid leukemia compared with chemotherapy, meeting the primary end point of the phase 3 COMMODORE confirmatory trial.

In an interview with Targeted Oncology, Erika P. Hamilton, MD, explained how hormone receptor status in patients with HER2-positive breast cancer was affected by treatment with the HER2CLIMB regimen of tucatinib plus trastuzumab and capecitabine.

Positive efficacy and safety results observed with the proposed trastuzumab biosimilar, EG12014 in HER2-positive early breast cancer, has led the developer to plan regulatory filings in the United States, Europe, and China.

In an interview with Targeted Oncology, Hun Ju Lee, MD, summarized the findings and future steps for the study of cirmtuzumab in patients with mantle cell lymphoma.

In relapsed and untreated patients with mantle cell lymphoma, the combination of obinutuzumab, ibrutinib, and venetoclax achieved molecular response rates and was found to be well tolerated, results from the phase 1/2 OAsIs trial demonstrate.

Administering corticosteroids prior to chimeric antigen receptor T-cell therapy with axicabtagene ciloleucel in adult patients with relapsed or refractory large B-cell lymphoma may positively impact the benefit/risk profile of axi-cel treatment.

177Lu-PSMA-617, a targeted radioligand therapy, demonstrated improvement in both progression-free survival and overall survival as treatment of patients with progressive PSMA-positive metastatic castration-resistant prostate cancer compared with best standard of care alone in the phase 3 VISION trial.

An update from the phase 3 IMpower010 study shows that the study has met its primary end point of improvement in disease-free survival with atezolizumab versus use of best supportive care as treatment of patients with non–small cell lung cancer.

Bexmarilimab, a novel anti-Clever-1 antibody, has shown signals of significant efficacy as a treatment of patients with 10 hard-to-treat solid tumors, according to an update from the phase 1/2 MATINS clinical trial.

Patients with advanced or recurrent endometrioid endometrial cancer had promising clinical outcomes following treatment with the combination of enzalutamide and carboplatin plus paclitaxel in the phase 2 ENPAC clinical trial.

Niraparib administered as maintenance therapy showed clinical benefit lasting beyond first progression in patients with platinum-sensitive recurrent ovarian cancer with or without germline BRCA mutations, according to the final results of the ENGOT-OV16/NOVA study.

The combination of tilsotolimod and ipilimumab demonstrated a low objective response rate in patients with anti–PD-1–refractory advanced melanoma, missing the coprimary end point of the phase 3 ILLUMINATE-301 trial.

In the United States, 1 in 3 patients with cancer and cancer survivors are unlikely to get or are unsure about getting a vaccine for COVID-19, according to a survey from The Leukemia & Lymphoma Society.

In advanced medullary thyroid cancer, mortality may be predicted by serum carbohydrate antigen 19.9 (Ca19.9) positivity in patients as well as by doubling times less than 6 months and less than 1 year. Results of a retrospective study suggest that these 2 new prognostic factors should be considered when initiating treatment for patients with MTC.

Patients with relapsed or refractory high-risk chronic lymphocytic leukemia achieved a statistically higher rate of overall response when the glycoengineered, type I anti-CD20 monoclonal antibody ublituximab was added to the Bruton’s tyrosine kinase inhibitor ibrutinib, according to results from the phase 3 GENUINE study.

The FDA has extended the review period for the New Drug Application for belumosudil, which is being considered as a potential treatment option for patients with chronic graft-versus-host disease.

The FDA granted orphan drug designation to the CDK2/4/6 inhibitor, NUV-422, for the treatment of patients with malignant gliomas.

The FDA granted Orphan Drug Designation to the novel GPER agonist, LNS8801, for the treatment of patients with metastatic uveal melanoma.

The first therapy for adults with relapsed or refractory advanced renal cell carcinoma who have received two or more prior systemic therapies has been granted approval by the FDA.