Nichole Tucker

The FDA granted approval to the Fc-engineered, monoclonal antibody margetuximab in combination with chemotherapy, as treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.

In an interview with Targeted Oncology, Mehmet Samur, PhD, discussed the investigation of high-dose melphalan following autologous stem cell transplant in patients with multiple myeloma and shared insights into how the ongoing questions can be explored in the future.

In an interview with Targeted Oncology, Jesus G. Berdeja, MD, discussed a subanalysis of the KarMMA study and updated results from CARTITUDE-1, which provide insights on the use CAR T-cell therapy in heavily pretreated patients with multiple myeloma, including the elderly and frail.

In patients with hormone receptor–positive, HER2-negative, node-positive, early breast cancer whose tumors have high clinicopathological risk factors, treatment with abemaciclib in combination with endocrine therapy educed the risk of invasive disease recurrence or death, independent of Ki-67 level, according to results from a subanalysis of the phase 3 monarchE clinical trial.

In older patients with comorbid classical Hodgkin lymphoma who are deemed unfit for combination chemotherapy, treatment with the antibody dug conjugate brentuximab vedotin appeared tolerable and achieved high response rates that were durable in some patients, according to results from the phase 2 SGN35-015 study.

The phase 1/2 study of the investigational chimeric antigen receptor T-cell agent BPX-601 administered as treatment of patients with previously treated metastatic pancreatic or prostate cancer is no longer active after the FDA place a partial clinical hold on the trial.

High response rates and robust survival outcomes among patients with chronic-phase chronic myeloid leukemia who failed prior treatment with a second-generation tyrosine kinase inhibitor were observed in 2 clinical trials of ponatinib,.

The combination of brentuximab vedotin and nivolumab demonstrated activity in patients with previously untreated Hodgkin lymphoma who had comorbidities in a phase 2 clinical trial, despite the trial not meeting its prespecified criteria for activity.

In patients with relapsed or refractory lymphoma, treatment with the investigational CD47-blocker TTI-622 appeared well tolerated and demonstrated preliminary activity, according to results from a phase 1a clinical trial presented in a poster during the 2020 American Society of Hematology Virtual Annual Meeting.

Allogeneic hematopoietic stem cell transplant with a donor leads to significant improvements in outcomes, even for patients up to age 75, in patients with higher-risk myelodysplastic syndrome.

Azacitidine administered orally to patients with acute myeloid leukemia demonstrated significant improvements in overall survival and relapse-free survival while sustaining the health-related quality of life compared with placebo.

The FDA pushed back its the Biologic License Application filing for the potential approval of balstilimab as treatment of recurrent/metastatic cervical cancer.

The novel first-in-class small molecule inhibitor of HIF-2α, PT2385 demonstrated the ability to stabilize disease with tolerable safety in patients with von Hippel-Lindau disease-associated clear cell renal cell carcinoma and non-renal tumors, according to results presented in a poster during the 21st Annual Meeting of the Society of Urologic Oncology.

In an interview with Targeted Oncology, Ajeet Gajra, MD, FACP, vice president, Cardinal Health, discussed the ongoing challenges community oncologists face with prescribing CAR T-cell therapy to patients with relapsed/refractory diffuse large B-cell lymphoma.

Patients with ALK-positive non–small cell lung cancer and brain metastases achieved better objective response rates and disease control rates when given ceritinib 450 mg with food compared with 750 mg whilst fasting, according to results from a real-world study.

The FDA has accepted a New Drug Application for the oral FGFR1-3 selective inhibitor, infigratinib and granted it Priority Review for the treatment of patients with cholangiocarcinoma.

The FDA has granted a Fast Track designation to the irinotecan liposome injection as a potential treatment option for patients with small cell lung cancer who progressed following a first-line platinum-based regimen, Ipsen announced, in a press release.

The FDA accepted the New Drug Application from belumosudil and granted it a Priority Review designation for the treatment of patients with chronic graft-versus-host disease. The Prescription Drug User Fee Act target action date has been set to May 30, 2021.

The FDA has granted approval to the naxitamab as treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease on prior treatment.

Investigators conducted post hoc analyses of the phase 3 JUMP clinical trial to determine how clinical characteristics correlate with response to therapy in patients with myelofibrosis.

The investigational engineered SPEAR T-cell agent, ADP-A2M4, induced durable responses in patients with synovial sarcoma, according to updated results from the phase 1 clinical trial presented during the Connective Tissue Oncology Society Annual Meeting.

Results from the study were published in Blood and showed that obinutuzumab plus ibrutinib and venetoclax as treatment of patients with relapsed and untreated mantle cell lymphoma achieved high response rates with favorable tolerability.

The FDA has accepted a Biologic License Application for loncastuximab tesirine as treatment of relapsed or refractory diffuse large B-cell lymphoma and granted it a Priority Review designation.

In an interview with Targeted Oncology during the Association for Molecular Pathology 2020 Annual Meeting, Rachel Sparks, MD, discussed the findings observed in hematologic malignancies with the use of a new RNA-based NGS assay.

For the majority of patients with medullary thyroid cancer, vandetanib and cabozantinib are both effective treatment options, according to results from a retrospective analysis.

In an interview with Targeted Oncology, Thomas E. Hutson, DO, PharmD, discussed the difficult-to-treat nccRCC patient population and the promise of lenvatinib plus everolimus, as well as other combination regimens.

The partial clinical hold placed by the FDA on the phase 1 chimeric antigen receptor T-cell clinical trial, MELANI-01, has now been lifted.

The FDA has granted a Fast Track designation to rilzabrutinib, an oral investigational Bruton’s tyrosine kinase inhibitor, for the treatment of immune thrombocytopenia. The drug was previously granted Orphan Drug designation for this indication.

Durable responses were shown with the investigational agent UGN-102 as treatment of patients with low-grade intermediate-risk non-muscle invasive bladder cancer, according to final results of the phase 2b OPTIMA II study .

In an interview with Targeted Oncology during the 2020 Association for Molecular Pathology Annual Meeting, Ozge Ceyhan-Birsoy, PhD, discussed genetic testing methods for patients with hereditary predisposition and the molecular research underway at MSKCC to improve testing in this patient population.