News

The FDA has accepted a biologics license application (BLA) for sacituzumab govitecan as a treatment for patients with metastatic triple-negative breast cancer (TNBC) who have received at least 2 prior therapies for metastatic disease, according to a statement from the company developing the antibody-drug conjugate (ADC), Immunomedics.

After decades of few advances and stagnant treatment approaches, which mainly comprised 7+3 chemotherapy, the acute myeloid leukemia (AML) paradigm now has several agents approved, and plenty of ongoing trials are exploring other novel therapies alone and in combination, according to Melissa L. Larson, MD.

The approval of novel agents, specifically blinatumomab (Blincyto) and CAR T-cell therapy, in the acute lymphoblastic leukemia (ALL) paradigm has led has to expanded options for pediatric, adolescent and young adult (AYA), and adult patients; however, ongoing trials are poised to keep moving the field forward, said Joseph Wynne, MD.

Three pivotal trials demonstrating improved metastasis-free survival (MFS) with 3 different oral antiandrogen agents in combination with androgen deprivation therapy (ADT) have led to FDA approvals that have transformed the treatment paradigm in nonmetastatic castration-resistant prostate cancer (CRPC), said Elisabeth I. Heath, MD, FACP.

The FDA has granted tucatinib a breakthrough therapy designation for use in combination with trastuzumab (Herceptin) and capecitabine (Xeloda) for the treatment of patients with unresectable locally advanced or metastatic HER2-positive breast cancer, including patients with brain metastases, who had prior trastuzumab, pertuzumab (Perjeta), and ado-trastuzumab emtansine (T-DM1; Kadcyla).

Residual cancer burden (RCB) after neoadjuvant chemotherapy has been shown to be an accurate long-term predictor of disease recurrence and survival across all breast cancer subtypes, according to data from a large meta-analysis presented at the 2019 San Antonio Breast Cancer Symposium.

A durvalumab (Imfinzi)-based neoadjuvant regimen induced a pathologic complete response (pCR) rate of 44% in patients with triple-negative breast cancer (TNBC), according to results of a phase I/II study presented in a poster at the 2019 San Antonio Breast Cancer Symposium.

Real-world clinical practice results for frontline palbociclib (Ibrance) indicate that the positive progression-free survival (PFS) data previously reported with the CDK4/6 inhibitor in the pivotal PALOMA-2 trial would likely translate to an overall survival (OS) benefit in patients with HR-positive/HER2-negative metastatic breast cancer.

The combination of lenalidomide (Revlimid) and obinutuzumab (Gazyva) elicited a 100% overall response rate (ORR) in patients with relapsed indolent non-Hodgkin lymphoma (NHL) that was refractory to rituximab (Rituxan), according to findings of a single-arm, phase I/II trial presented at the 2019 ASH Annual Meeting.

Resistance to aromatase inhibitors (AIs) is a growing concern in patients with advanced hormone receptor (HR)–positive, HER2-negative breast cancer, said Hope S. Rugo, MD, FASCO, who added that although fulvestrant (Faslodex) has shown some activity in patients who develop ESR1 mutations, more effective treatment options are needed.