Jason M. Broderick

The FDA has granted a full approval to palbociclib (Ibrance) for use in combination with letrozole as a frontline treatment for postmenopausal women with ER-positive, HER2-negative metastatic breast cancer.

The FDA has granted a priority review to a supplemental biologics license application supporting the conversion of the accelerated approval of blinatumomab to a full approval as a treatment for patients with Philadelphia chromosome-negative relapsed/refractory B-precursor acute lymphoblastic leukemia.

The FDA's Oncologic Drugs Advisory Committee unanimously (11-0) recommended approval of subcutaneous rituximab for the treatment of patients with certain blood cancers.

The FDA has granted a priority review to a new drug application for olaparib (Lynparza) as a maintenance therapy in relapsed patients with platinum-sensitive ovarian cancer, according to AstraZeneca, the manufacturer of the PARP inhibitor.

The FDA has approved the PARP inhibitor niraparib (Zejula) for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.

The China Food and Drug Administration has approved osimertinib for the treatment of patients with locally-advanced or metastatic EGFR T790M-positive non-small cell lung cancer with progression following treatment with an EGFR tyrosine kinase inhibitor.

The EMA’s Committee for Medicinal Products for Human Use has recommended approval of pembrolizumab for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma who have progressed following autologous stem cell transplant and brentuximab vedotin, or who are transplant-ineligible and have failed brentuximab vedotin.

The EMA’s Committee for Medicinal Products for Human Use has recommended approval of nivolumab for the treatment of patients with squamous cell cancer of the head and neck following progression on platinum-based therapy.

The FDA has granted an accelerated approval to the PD-L1 inhibitor avelumab (Bavencio) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma, including those who have not received prior chemotherapy.

The combination of rituximab, bendamustine, and low-dose cytarabine is an effective induction regimen for elderly patients with mantle cell lymphoma.

In the phase III MONARCH 2 study, adding abemaciclib to fulvestrant improved progression-free survival compared with fulvestrant alone in women with hormone receptor-positive/HER2-negative breast cancer.

The FDA has granted an accelerated approval to pembrolizumab (Keytruda) for the treatment of adult and pediatric patients with classical Hodgkin lymphoma (cHL) who are refractory or have relapsed after 3 or more lines of therapy.

The FDA has placed a partial clinical hold on trials of selinexor (KPT-330), which is being explored in several tumor types.

The FDA has approved the CDK 4/6 inhibitor ribociclib (Kisqali) for use in combination with an aromatase inhibitor as a frontline treatment for postmenopausal women with hormone-receptor (HR)-positive, HER2-negative advanced breast cancer.

The success of olaparib in a phase III trial and recent data for other emerging agents has reversed the PARP narrative in breast cancer, Kimberly Blackwell, MD, said in a presentation at the 34th Annual Miami Breast Cancer Conference.

Adding CDK4/6 and mTOR inhibitors to standard endocrine therapy has significantly improved outcomes in patients with hormone receptor-positive, HER2-negative advanced breast cancer, William J, Gradishar, MD, explained in a presentation at the 34th Annual Miami Breast Cancer Conference.

A supplemental biologics license application for pembrolizumab (Keytruda) for previously treated patients with advanced microsatellite instability-high cancer remains under review by the FDA.

Adding ribociclib to frontline letrozole reduced the risk of disease progression or death by 40% in elderly patients with hormone receptor-positive, HER2-negative advanced breast cancer, according to a subgroup analysis of the phase III MONALEESA-2 trial presented at the 34th Annual Miami Breast Cancer Conference.

The FDA has lifted its clinical hold on several phase I trials of the antibody-drug conjugate vadastuximab talirine (SGN-CD33A) in acute myeloid leukemia.

Denosumab (Xgeva) demonstrated noninferiority to zoledronic acid (Zometa) at delaying the time to the first skeletal-related event in patients with multiple myeloma, according to the full results of the phase III 482 study presented at the 16th International Myeloma Workshop in New Delhi.

Treatment with blinatumomab (Blincyto) led to a median overall survival of 7.7 months versus 4 months with standard chemotherapy in patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia, according to results from the phase III TOWER study published in The New England Journal of Medicine.

Adding pertuzumab (Perjeta) to trastuzumab (Herceptin) and chemotherapy reduced the risk of recurrence of invasive disease or death in patients with HER2-positive early breast cancer, according to findings from the phase III APHINITY study.

Carfilzomib (Kyprolis) plus dexamethasone improved overall survival by 21% versus dexamethasone plus bortezomib (Velcade) in patients with relapsed or refractory multiple myeloma, according to findings from the phase III ENDEAVOR trial.

The FDA has approved telotristat ethyl (Xermelo) for use in combination with somatostatin analog (SSA) as a treatment for carcinoid syndrome diarrhea in patients with metastatic neuroendocrine tumors that cannot be adequately controlled by SSA therapy alone.

The FDA has granted a priority review to a biologics license application for avelumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has progressed after platinum-based therapy.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of oral rolapitant (Varuby; Varubi in US) for the prevention of delayed nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy.

The European Commission has approved alectinib (Alecensa) as a treatment for patients with metastatic ALK-positive non–small cell lung cancer following progression on crizotinib (Xalkori).

The EMA’s Committee for Medicinal Products for Human Use has recommended approval of daratumumab (Darzalex) in combination with lenalidomide (Revlimid) and dexamethasone or bortezomib (Velcade) and dexamethasone for patients with relapsed multiple myeloma following at least 1 prior therapy.

The EMA’s Committee for Medicinal Products for Human Use has recommended approval of the combination of dabrafenib (Tafinlar) and trametinib (Mekinist) as a treatment for patients with advanced or metastatic BRAF V600E-mutant non-small cell lung cancer.

The European Commission has expanded the indication for lenalidomide (Revlimid) to include use as a maintenance therapy for patients with multiple myeloma following autologous hematopoietic stem cell transplant.