Caroline Seymour

The Center for Drug Evaluation of the China National Medical Products Administration has accepted the biologics license application for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who received prior treatment with a PD-1/L1 inhibitor and platinum-based chemotherapy.

The FDA’s Oncologic Drugs Advisory Committee voted 11 to 2 that data from the phase 3 POLARIX trial support a favorable benefit-risk profile for polatuzumab vedotin-piiq in patients with previously untreated large B-cell lymphoma, including diffuse large B-cell lymphoma not otherwise specified.

After settling the debate of which patients with early-stage, hormone receptor–positive breast cancer require chemotherapy in addition to endocrine therapy, investigators have set their sights on determining whether ovarian function suppression can deliver the same effects of chemotherapy and when to recommend abemaciclib and olaparib.

By moving away from adjuvant- to neoadjuvant-based protocols, such as I-SPY, investigators may be better able to develop effective treatments for patients in less time by refining the understanding of who will benefit from therapy, enabling strategies with multiple pathway targets, and testing approaches earlier in the disease course.

The FDA has granted an orphan drug designation to the CEACAM1/5 antibody YB-200 for the treatment of patients with hepatocellular carcinoma.

The addition of pembrolizumab to standard therapies failed to improve survival outcomes in patients with metastatic castration-resistant prostate cancer in the KEYNOTE-641 trial and patients with EGFR-mutated non–small cell lung cancer in the KEYNOTE-789 trial.

Despite treatment with the chemoprotective agent ALRN-6924, patients with p53-mutated breast cancer receiving neoadjuvant or adjuvant therapy with docetaxel, doxorubicin, and cyclophosphamide failed to meet the trial’s primary and secondary end points of duration and incidence of severe neutropenia in cycle 1 and incidence of chemotherapy-induced alopecia, respectively.

Toripalimab plus nab-paclitaxel demonstrated a significant improvement in progression-free survival compared with placebo and nab-paclitaxel in PD-L1–positive patients with stage IV or recurrent/metastatic triple-negative breast cancer.

Atezolizumab monotherapy failed to show an improvement in overall survival compared with placebo plus platinum-based chemotherapy and gemcitabine in patients with untreated locally advanced or metastatic urothelial cancer.

Orca-T produced a 100% overall survival rate in 8 patients with hematologic malignancies who received an allogeneic hematopoietic stem cell transplant with 7/8 non-permissive HLA mismatched donors.

The dual CD19- and CD20-directed, freshly administered CAR T-cell therapy zamtocabtagene autoleucel elicited a high response rate with deepening responses over time in patients with relapsed/refractory diffuse large B-cell lymphoma.

Toripalimab plus gemcitabine and cisplatin demonstrated a statistically significant and clinically meaningful improvement in overall survival compared with chemotherapy alone as frontline therapy in patients with recurrent or metastatic nasopharyngeal carcinoma.

The FDA has placed a partial clinical hold on the phase 1/2 VELA trial due to visual adverse effects observed in select patients who received the investigational treatment BLU-222.

In an 8 to 5 vote, the FDA’s ODAC voted that data from two proposed single-arm trials will provide adequate means of characterizing the risk-benefit profile of dostarlimab for the treatment of patients with dMMR/MSI-H locally advanced rectal cancer.

The FDA has granted an orphan drug designation to ezurpimtrostat, a PPT-1 inhibitor for the treatment of patients with hepatocellular carcinoma.

Avero Diagnostics has launched AMBLor, a first-of-its-kind laboratory test for the identification of early-stage melanoma at low risk of progression.

Treatment with crovalimab led to disease control through transfusion avoidance and control of hemolysis in patients with paroxysmal nocturnal hemoglobinuria who have not been previously treated with complement inhibitors.

If the FDA’s Oncologic Drugs Advisory Committee meeting held on February 10, 2022, was any indication, the days of applying foreign single country or region data to support regulatory approval are gone; instead, regulatory decisions are headed toward the need for regional consistency through multiregional clinical trials, which could help the United States overcome the persistent underrepresentation of racial and ethnic minorities in drug development.

The FDA has accepted for review a biologics license application for a proposed denosumab biosimilar, according to an announcement from Sandoz, Inc.

Revumenib resulted in deep response rates, facilitating subsequent transplant in patients with KMT2A-rearranged or NMP1-mutant, relapsed/refractory acute myeloid leukemia.

The FDA has granted an orphan drug designation to BEA-17 for the treatment of patients with glioblastoma.

A biologics license application seeking the approval of remestemcel-L has been resubmitted to the FDA for the treatment of pediatric patients with steroid-refractory, acute graft-vs-host-disease.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the approval of luspatercept for the treatment of patients with anemia associated with non–transfusion dependent beta thalassemia.

Fam-trastuzumab deruxtecan-nxki has received approval in the European Union as a single agent for the treatment of patients with unresectable or metastatic HER2-low breast cancer who have received prior chemotherapy for metastatic disease or developed disease recurrence during or within six months of completing adjuvant chemotherapy.

Maintenance therapy with carfilzomib, lenalidomide, and dexamethasone led to a significant improvement in progression-free survival vs lenalidomide alone in patients with newly diagnosed multiple myeloma who underwent autologous stem cell transplant after induction therapy, according to an unplanned interim analysis of the phase 3 ATLAS trial.

Adding the PD-1 inhibitor pembrolizumab to gemcitabine and cisplatin led to a significant improvement in overall survival compared with gemcitabine and cisplatin alone as first-line therapy in patients with advanced or unresectable biliary tract cancer.

Autologous stem cell transplant had no effect on real-world time to next treatment and overall survival compared with maintenance rituximab following induction with bendamustine and rituximab or R-CHOP, for patients with mantle cell lymphoma according to findings from a retrospective study.

The FDA has granted a fast track designation to DB-1303 for the treatment of patients with advanced, recurrent or metastatic endometrial cancer with HER2 overexpression who have progressed on or after standard systemic therapy.

The addition of stereotactic body radiation therapy to sorafenib led to an improvement in overall survival, progression-free survival, and time to disease progression compared with sorafenib alone in patients with locally advanced, hepatocellular carcinoma.

The FDA has granted an orphan drug designation to LNS8801 for the treatment of patients with metastatic cutaneous melanoma.