Midostaurin (Rydapt) has been approved by the FDA for the treatment of adult patients with newly diagnosed <em>FLT3</em>-positive acute myeloid leukemia (AML) in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation.
Regorafenib has been approved by the FDA as a second-line treatment for patients with unresectable hepatocellular carcinoma who have previously received sorafenib.
The addition of abemaciclib to letrozole or anastrozole improved progression-free survival over either aromatase inhibitor alone in women with HR+/HER2-negative breast cancer enrolled in the phase III MONARCH 3 study.
Veliparib fell short of meeting the primary endpoint in a phase III non–small cell lung cancer trial and a triple-negative breast cancer trial.
Tisagenlecleucel-T has been granted a breakthrough therapy designation by the FDA for use as a treatment for adult patients with relapsed/refractory diffuse large B-cell lymphoma after the failure of at least 2 prior therapies.
Atezolizumab (Tecentriq) has been granted an accelerated approval by the FDA as a frontline treatment for cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma.
An Oncologic Drugs Advisory Committee hearing has been scheduled by the FDA for May 24, 2017, to discuss a new drug application for neratinib as a treatment for patients with HER2-positive breast cancer following prior treatment with postoperative trastuzumab.
According to findings from the phase III ALEX trial, alectinib reduced the risk of disease progression or death compared with crizotinib as a frontline treatment for patients with <em>ALK</em>-positive non–small cell lung cancer.
Combining the IDO inhibitor indoximod with pembrolizumab led to an overall response rate of 52% in patients with advanced melanoma.
FDA approval is being sought for the use of denosumab for the prevention of skeletal-related events in patients with multiple myeloma, according to Amgen, the developer of the RANK ligand inhibitor.
According to results of the phase II JAVELIN Merkel 200 study, the PD-L1 inhibitor avelumab (Bavencio) induced an objective response rate (ORR) of 33% in patients with advanced Merkel cell carcinoma, including 2 additional complete responses (CR) since the primary analysis.
Palbociclib (Ibrance) has been granted a full approval by the FDA 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 (sBLA) supporting the conversion of the accelerated approval of blinatumomab (Blincyto) to a full approval as a treatment for patients with Philadelphia chromosome-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).
Subcutaneous rituximab has received the FDA’s Oncologic Drugs Advisory Committee (ODAC) unanimous (11-0) recommended approval for the treatment of patients with certain blood cancers.
A new drug application (NDA) for olaparib (Lynparza) as a maintenance therapy in relapsed patients with platinum-sensitive ovarian cancer has been granted a priority review by the FDA.
The PARP inhibitor niraparib (Zejula) has been approved by the FDA 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.
Pembrolizumab has been recommended for approval by the EMA’s Committee for Medicinal Products for Human Use for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma.
Nivolumab (Opdivo) has been recommended for approval by EMA’s Committee for Medicinal Products for Human Use for the treatment of patients with squamous cell cancer of the head and neck following progression on platinum-based therapy.
The PD-L1-inhibitor avelumab (Bavencio) has been granted an accelerated approval by the FDA for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma.
The combination of rituximab, bendamustine, and low-dose cytarabine demonstrated a high complete response rate as an induction regimen for elderly patients with mantle cell lymphoma.
Progression-free survival was improved by adding abemaciclib to fulvestrant compared with fulvestrant alone in women with HR+/HER2-negative breast cancer enrolled in the phase III MONARCH 2 study.
Clinical trials of selinexor, which is being explored in several tumor types, have been placed on clinical hold by the FDA.
The CDK 4/6 inhibitor ribociclib has been approved by the FDA for use in combination with an aromatase inhibitor for the frontline treatment of postmenopausal women with hormone-receptor–positive, HER2-negative advanced breast cancer.
Kimberly Blackwell, MD, discusses the results of the recent phase III OLYMPIAD trial, which showed olaparib (Lynparza) improved progression-free survival (PFS) versus standard chemotherapy in patients with <em>BRCA</em>-positive breast cancer.
The addition of CDK4/6 and mTOR inhibitors to standard endocrine therapy has significantly improved outcomes in patients with hormone receptor (HR)–positive, HER2-negative advanced breast cancer.
The addition of the CDK4/6 inhibitor 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.
Clinical holds on several phase I trials of vadastuximab talirine in acute myeloid leukemia have been lifted by the FDA.
The addition of pertuzumab to trastuzumab and chemotherapy reduced the risk of recurrence of invasive disease or death in patients with HER2-positive early breast cancer in the phase III APHINITY study.
Alectinib has been approved by the European Commission as a treatment for patients with metastatic ALK-positive non–small cell lung cancer following progression on crizotinib.
PFS was improved with Olaparib versus standard chemotherapy in patients with <em>BRCA</em>-positive, HER2-negative breast cancer, according to findings from the phase III OLYMPIAD trial.