Silas Inman

The irreversible pan-HER tyrosine kinase inhibitor neratinib showed single-agent activity across cohorts of patients with HER2-mutant advanced cancers.

A biologics license application has been submitted for axicabtagene ciloleucel as a potential treatment for transplant ineligible patients with relapsed or refractory aggressive non-Hodgkin lymphoma.

The FDA has granted a regular approval to osimertinib as a treatment for patients with metastatic EGFR T790M mutation-positive non–small cell lung cancer following prior treatment with an EGFR TKI, based on progression-free survival findings from the phase III AURA3 trial.

The FDA has granted a priority review designation to tisagenlecleucel-T as a treamtnet for pediatric and young adult patients with relapsed and refractory B-cell acute lymphoblastic leukemia, making it the first CAR T-cell therapy to enter regulatory review.

Array BioPharma has withdrawn its new drug application for binimetinib as a treatment for patients with NRAS-mutant advanced melanoma, based on feedback from the FDA during a preplanned review meeting.

Multiple ongoing clinical trials are evaluating various immunotherapy strategies for patients with breast cancer, with combinations representing the most potential for future success.

It is imperative that surgeons remain involved in genetic counseling to meet the immense unmet need that exists for patients with breast cancer, given a shortage of available genetic counselors.

Imatinib continued to show dramatic overall survival benefits after nearly 11 years of follow-up despite crossover for patients with Philadelphia chromosome-positive chronic myelogenous leukemia in the chronic phase.

The combination of eribulin and pembrolizumab demonstrated promising objective response rates, including a complete response, for patients with metastatic triple-negative breast cancer.

The addition of ublituximab to ibrutinib significantly improved objective response rates compared with ibrutinib alone for patients with previously treated high-risk chronic lymphocytic leukemia.

Juno therapeutics has shifted its focus toward the development of JCAR017 for relapsed/refractory diffuse large B-cell lymphoma after a series of toxicity-related setbacks culminated in the need to halt the development of JCAR015.

The FDA has granted a priority review to a new drug application for enasidenib as a treatment for patients with relapsed or refractory IDH2-mutated acute myeloid leukemia.

Treatment with axicabtagene ciloleucel demonstrated an objective response rate of 82% and a complete response rate of 54% for patients with aggressive non-Hodgkin lymphoma.

Prophylactic treatment with letermovir lowered the rates of cytomegalovirus infection and all-cause mortality compared with placebo for CMV-seropositive patients following an allogeneic hematopoietic stem cell transplant.

Treatment with an inactivated varicella zoster virus vaccine, known as V212, lowered the cumulative incidence rate of herpes zoster infection and complications for patients undergoing autologous hematopoietic stem cell transplantation.

Treatment with pembrolizumab could elicit long-term survival rates of 21% to 25% for previously-treated patients with PD-L1–positive non–small cell lung cancer compared with 3% to 4% for docetaxel.

More patients with acute myeloid leukemia could proceed to transplant following treatment with CPX-351 compared with the traditional 7+3 chemotherapy regimen.

An Independent Data Monitoring Committee has recommended halting the phase III ADAPT trial exploring rocapuldencel-T (AGS-003) for the frontline treatment of metastatic renal cell carcinoma.

The FDA has granted a priority review designation to inotuzumab ozogamicin for the treatment of patients with relapsed or refractory acute lymphoblastic leukemia.

The genomic-based Decipher test effectively predicted metastasis and prostate cancer-specific mortality from diagnostic biopsy specimens for patients with intermediate- and high-risk prostate cancer.

Tivantinib failed to improve overall survival compared with placebo as a second-line therapy for patients with MET-overexpressing inoperable hepatocellular carcinoma in the phase III METIV-HCC study.

Combination regimens that pair nab-paclitaxel with PD-L1 checkpoint blockade immunotherapy agents are emerging as a robust area of investigation in triple-negative breast cancer, bolstered by clinical trial results that establish the chemotherapeutic agent as an effective partner for other therapies.

The FDA has granted a priority review to pembrolizumab as a treatment for cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma, according to Merck, the developer of the PD-1 inhibitor.

The European Commission has expanded the indication for pembrolizumab to include the frontline treatment of patients with metastatic non–small cell lung cancer that expresses PD-L1 on ≥50% of cells and does not harbor an EGFR or ALK mutation.

Novel combination approaches are being explored that hope to capitalize on the high rates of complete remissions seen with CAR T-cell therapies for patients with hematologic malignancies.

Bristol-Myers Squibb and AstraZeneca have each announced separate delays in the development of PD-1 and CTLA-4 inhibitor combinations as first-line therapies for patients with advanced or metastatic non–small cell lung cancer.

Treatment with nivolumab reduced the risk of death by 37% compared with placebo for patients with advanced gastric or gastroesophageal junction cancer following second or later-line chemotherapy.

The FDA has granted an accelerated approval to ibrutinib as a treatment for patients who require systemic therapy with marginal zone lymphoma following at least one prior anti-CD20-based therapy, based on findings from a single-arm phase II study.

The FDA has granted a priority review to a supplemental biologics license application for pembrolizumab in combination with pemetrexed plus carboplatin as a treatment for patients with metastatic or advanced non-squamous non–small cell lung cancer, regardless of PD-L1 expression and without EGFR or ALK mutations.

The addition of PEGPH20 to standard nab-paclitaxel and gemcitabine demonstrated improvements in progression-free survival compared with nab-paclitaxel/gemcitabine alone for untreated patients with advanced pancreatic cancer.