Gina Columbus

The FDA has granted a fast track designation to the CCR5 antagonist leronlimab for use in combination with carboplatin for the treatment of patients with CCR5-positive metastatic triple-negative breast cancer.

Acalabrutinib improved progression-free survival compared with rituximab plus either idelalisib or bendamustine in previously treated patients with chronic lymphocytic leukemia, according to findings from the phase III ASCEND trial.

A loperamide prophylactic regimen with or without the addition of either budesonide or colestipol in patients with HER2-positive early breast cancer who received treatment with neratinib (Nerlynx) led to a significant reduction in incidence and severity of diarrhea.

The antibody-drug conjugate mirvetuximab soravtansine demonstrated a favorable benefit-risk profile in a prespecified subset of patients with folate receptor alpha–positive ovarian cancer, following a comprehensive analysis of the phase III FORWARD I trial.

The FDA has approved ado-trastuzumab emtansine (T-DM1; Kadcyla) for use as an adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease following neoadjuvant trastuzumab and chemotherapy.

In an effort to improve outcomes for intermediate- or poor-risk patients with renal cell carcinoma, the phase III COSMIC-313 trial is being initiated, which will evaluate cabozantinib (Cabometyx) in combination with nivolumab and ipilimumab in patients with previously untreated advanced disease.

The FDA has approved a supplemental new drug application for ivosidenib as a single agent for the first-line treatment of adult patients with IDH1-mutant acute myeloid leukemia, as detected by an FDA-approved test, who are ≥75 years old or are ineligible to receive intensive chemotherapy.

Sandoz has entered into an agreement with EirGenix, Inc., to commercialize the proposed trastuzumab biosimilar EG12014 for use as a treatment of patients with HER2-positive breast and select gastric cancers.

A supplemental new drug application has been submitted to the FDA for the approval of apalutamide (Erleada) for use as a treatment of patients with metastatic castration-sensitive prostate cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended that the conditional marketing authorization for olaratumab be revoked following results of the ANNOUNCE study, which did not demonstrate a survival benefit with the PDGFRα antagonist in combination with doxorubicin versus doxorubicin alone in patients with advanced or metastatic soft tissue sarcoma.

The FDA has granted a priority review designation to a new drug application for darolutamide for use as a treatment for patients with nonmetastatic castration-resistant prostate cancer.

The European Committee for Medicinal Products for Human Use has recommended approval of olaparib as a frontline maintenance treatment for patients with BRCA-mutant advanced high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response following first-line platinum-based chemotherapy.

A marketing authorization application has been submitted to the European Medicines Agency for luspatercept for the treatment of adult patients with very low- to intermediate-risk myelodysplastic syndrome–associated anemia with ring sideroblasts who require red blood cell transfusions and have not received or are ineligible to receive erythropoiesis-stimulating agents.

The combination of pembrolizumab (Keytruda) and chemotherapy did not improve overall survival or progression-free survival compared with standard chemotherapy alone for the frontline treatment of patients with advanced gastric or gastroesophageal junction adenocarcinoma.

Eli Lilly and Company has announced that it is withdrawing its PDGFRα antagonist olaratumab from the market for the treatment of patients with advanced soft tissue sarcoma.

The combination of lenalidomide (Revlimid) with rituximab (Rituxan), cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP; R2-CHOP) did not improve progression-free survival compared with placebo and R-CHOP as a frontline therapy in patients with activated B-cell-type diffuse large B-cell lymphoma, missing the primary endpoint of the phase III ROBUST trial.

Tagraxofusp led to a 90% overall response rate as a first-line therapy in patients with blastic plasmacytoid dendritic cell neoplasm.

A new VENTANA HER2 dual in situ hybridization companion diagnostic assay has launched to identify HER2 amplification for patients with breast cancer and gastric cancer who could be eligible to receive trastuzumab.

The FDA has approved pembrolizumab in combination with axitinib for the frontline treatment of patients with advanced renal cell carcinoma.

The FDA has scheduled an Oncologic Drugs Advisory Committee hearing for May 14, 2019, to discuss a new drug application for pexidartinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor.

The FDA has expanded the approval of the PD-L1 IHC 22C3 pharmDX assay, allowing the test to be used as a companion diagnostic to identify more patients with stage III or metastatic non–small cell lung cancer who can undergo first-line treatment with pembrolizumab (Keytruda).

Daratumumab was associated with low overall response rates in patients with relapsed/refractory diffuse large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma, missing the primary endpoint of a phase II trial published in Clinical Lymphoma, Myeloma & Leukemia.1

The FDA has expanded the approval for pembrolizumab monotherapy for the frontline treatment of patients with stage III non–small cell lung cancer, who are ineligible for surgery or definitive chemoradiation, or metastatic NSCLC, with a PD-L1 expression (tumor proportion score) level of ≥1% and do not harbor EGFR or ALK aberrations.

The European Commission has approved olaparib (Lynparza) for the treatment of adult patients with germline BRCA1/2-mutant, HER2-negative locally advanced or metastatic breast cancer.

For women at average risk for breast cancer who are between the ages of 40 and 49 years, clinicians should have a personalized approach on whether their patients should be screened with mammography prior to the age of 50.

A biologics license application has been resubmitted to the FDA for the pegfilgrastim biosimilar LA-EP2006 to decrease the incidence of infection from febrile neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer therapy.

A supplemental biologics license application has been submitted to the FDA for luspatercept for the treatment of adult patients with very low- to intermediate-risk myelodysplastic syndrome–associated anemia with ring sideroblasts who require red blood cell transfusions, and also for adult patients with beta-thalassemia–associated anemia who require such transfusions.

The FDA has expanded the approval of palbociclib capsules in combination with endocrine therapy for male patients with hormone receptor–positive, HER2-negative advanced or metastatic breast cancer.

Primary tumor surgery for patients with stage IV HER2-positive breast cancer is associated with an improvement in overall survival, according to results of a retrospective cohort review presented at the 2019 AACR Annual Meeting.

Maintenance therapy with rucaparib maintained disease control and was well tolerated in patients with platinum-sensitive, advanced BRCA1/2- or PALB2-mutant pancreatic cancer, according to preliminary interim findings of a single-arm, phase II trial.