Jason M. Broderick

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,&nbsp;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)&ndash;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&ndash;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.

Telotristat ethyl has been approved by the FDA for use in&nbsp;combination with somatostatin analog as a treatment for carcinoid syndrome diarrhea&nbsp;in patients with metastatic neuroendocrine tumors.

A biologics license application for avelumab has been granted a priority review by the FDA for the treatment of patients with locally advanced or metastatic urothelial carcinoma.

Ceritinib has been granted a priority review by the FDA as a first-line treatment for patients with <em>ALK</em>-positive, metastatic NSCLC.

Lenalidomide has been approved by the FDA as a maintenance therapy for patients with multiple myeloma following autologous hematopoietic stem cell transplant.

A full regulatory approval is being sought for blinatumomab as a treatment for patients with Philadelphia chromosome-negative relapsed/refractory B-precursor ALL.

A supplemental Biologics License Application for pembrolizumab has been granted a priority review by the FDA for the treatment of patients with locally advanced or metastatic urothelial cancer who progress following platinum-containing chemotherapy.

Based on data from 2 phase III trials, the EMA&rsquo;s CHMP has recommended approval of lenalidomide as a maintenance therapy following autologous stem cell transplant for patients with newly diagnosed multiple myeloma.

Lenvatinib was shown to be noninferior to standard therapy with sorafenib in the frontline treatment of patients with unresectable hepatocellular carcinoma.

In an update of the phase II CheckMate-142 trial,&nbsp;the promising antitumor activity of nivolumab in patients with microsatellite instability-high metastatic colorectal cancer was sustained.

Pathologic complete response (pCR) rates were improved by switching neoadjuvant chemotherapy regimens based on PET imaging after induction chemotherapy in patients with esophageal and gastroesophageal junction (GEJ) cancers, according to findings from the phase II CALGB 80803 study.

A supplemental new drug application for the PD-L1 inhibitor atezolizumab has been granted priority review by the FDA in cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma as a frontline therapy or following progression occurring &ge;12 months after neoadjuvant or adjuvant chemotherapy.

The clinical hold on trials exploring pacritinib has been lifted by the FDA, according to CTI BioPharma, the developer of the JAK2/FLT3 inhibitor.

A supplemental new drug application (sNDA) for the use of regorafenib (Stivarga) as a second-line treatment for patients with unresectable hepatocellular carcinoma (HCC) has been granted priority review by the FDA.