Jason M. Broderick

Pegylated liposomal irinotecan (Onivyde) in combination with fluorouracil (5-FU) and leucovorin has been approved by the European Commission (EC) for patients with metastatic pancreatic adenocarcinoma.

Pembrolizumab (Keytruda) has received FDA approval for the frontline treatment of patients with metastatic non­–small cell lung cancer (NSCLC) whose tumors have ≥50% PD-L1 expression based on an FDA-approved test and who do not harbor EGFR or ALK aberrations.

The FDA has updated the label for enzalutamide (Xtandi) in metastatic castration-resistant prostate cancer (mCRPC) to include new data from the phase II TERRAIN study, according to the codevelopers of the androgen receptor inhibitor, Astellas and Pfizer.

Findings of the phase III KEYNOTE-045 trial showed pembrolizumab (Keytruda) demonstrated improved survival compared with chemotherapy in previously treated patients with advanced urothelial cancer.

The PDGFRα antagonist olaratumab (Lartruvo) has been granted an accelerated approval from the FDA in combination with doxorubicin for the treatment of patients with advanced soft tissue sarcoma (STS) who are not candidates for radiotherapy or surgery.

Atezolizumab has received FDA approval for the treatment of patients with metastatic NSCLC who have progressed after a platinum-containing regimen and an FDA-approved targeted therapy for those patients harboring <em>EGFR</em> or <em>ALK</em> abnormalities.&nbsp;

The positive opinion for the BCL-2 inhibitor has been sent to the European Commission, which usually issues its final approval decision within 2 to 3 months of the CHMP recommendation.

Results from the KRISTINE^&nbsp;and NSABP B-41&nbsp;trials provided the latest data on the use of pertuzumab, trastuzumab, ado-trastuzumab emtansine, and lapatinib for the neoadjuvant treatment of patients with HER2-positive breast cancer.

Cabozantinib (Cabometyx) reduced the risk of progression or death by 31% compared with sunitinib (Sutent) in the frontline setting for patients with metastatic renal cell carcinoma (RCC).

Atezolizumab (Tecentriq) reduced the risk of death by 27% compared with docetaxel in patients with advanced non&ndash;small cell lung cancer (NSCLC) following the failure of platinum-based chemotherapy.

Updated findings from the phase III EORTC 18071 trial show treatment with ipilimumab (Yervoy) reduced the risk of death by 28% versus placebo in patients with high-risk stage III melanoma.&nbsp;

Over one-fourth of patients with metastatic melanoma in Europe do not have access to groundbreaking therapies that could extend their lives, according to a survey presented at the 2016 ESMO Congress.

In a 14-0 vote, the FDA&rsquo;s Oncologic Drugs Advisory Committee (ODAC) denied the approval of apaziquone (EOquin; Qapzola) for intravesical instillation immediately following transurethral resection in patients with non-muscle invasive bladder cancer.

A type II variation application for the use of nivolumab (Opdivo) as a treatment for patients with locally advanced unresectable or metastatic urothelial carcinoma (mUC) who have progressed following platinum-based chemotherapy is now under formal review.

Jennifer Woyach, MD, offers her expert insight into the practical clinical use of CLL treatments.

Findings from a recent phase II trial¹showed that combining&nbsp;the diabetes drug metformin with everolimus (Afinitor) and letrozole resulted in a clinical benefit rate (CBR) of 60% in women with advanced or recurrent endometrioid endometrial cancer.

According to results from the phase III ASCEND-4 trial, ceritinib (Zykadia) improved progression-free survival (PFS) compared with standard chemotherapy as a first-line treatment for patients with <em>ALK</em>-positive non&ndash;small cell lung cancer (NSCLC)

Bruce Cheson, MD,&nbsp;outlines the treatment choices for each of the 3 patient categories of CLL, noting that, regardless of the treatment, &ldquo;a clinical trial is always the preferred option.&rdquo;

The PDGFR&alpha; antagonist olaratumab has been recommended approval by&nbsp;The Committee for Medicinal Products for Human Use (CHMP)&nbsp;for use in combination with doxorubicin for patients with advanced soft tissue sarcoma (STS) who are not good candidates for radiotherapy or surgery.

The European Commission (EC) has granted its approval for lenvatinib (Kisplyx; EU) in combination with everolimus (Afinitor) for patients with advanced renal cell carcinoma (RCC) following 1 prior VEGF-targeted therapy.

Merck, the manufacturer of pembrolizumab (Keytruda), has announced the FDA has granted priority review to a supplemental biologics license application (sBLA) for the PD-1 inhibitor as a first-line treatment for patients with PD-L1-positive non-small cell lung cancer (NSCLC).

Blinatumomab (Blincyto) has received accelerated approval from the FDA for the treatment of pediatric and adolescent patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

<div>The developer of neratinib, Puma Biotechnology, has announced the European Medicines Agency (EMA) has validated the marketing authorization application for neratinib as a potential extended adjuvant therapy for patients with HER2-positive early stage breast cancer following 12 months of trastuzumab (Herceptin).</div>

Pembrolizumab (Keytruda) demonstrated promising antitumor activity with durable responses in patients with advanced thyroid cancer, according to results from the KEYNOTE-028 trial presented at the 2016 ASCO Annual Meeting. The overall response rate (ORR) with the PD-1 inhibitor was 9.1%, which included 2 partial responses (PR).

Priority review has been granted by the FDA for a new drug application (NDA) for rucaparib as a treatment for patients with&nbsp;<em>BRCA</em>-positive advanced ovarian cancer who have received at least 2 prior lines of chemotherapy, according to Clovis, the manufacturer of the PARP inhibitor.

The extended release injection formulation of granisetron (Sustol) has been approved by the FDA for use in combination with other antiemetic therapies for the prevention of chemotherapy-induced nausea and vomiting (CINV), according to Heron Therapeutics, the manufacturer of the treatment.

The FDA has placed a partial clinical hold on a planned pivotal trial examining NY-ESO SPEAR T-cell therapy in patients with myxoid round cell liposarcoma.

Pracinostat has received a breakthrough therapy designation from the FDA, when given in combination with azacitidine, for the treatment of patients with newly diagnosed acute myeloid leukemia (AML) aged 75 years or older, or for those who are ineligible for intensive chemotherapy, according to MEI Pharma, the company developing pracinostat.

Daratumumab (Darzalex) has been granted a breakthrough therapy designation by the FDA for use in the treatment of patients with multiple myeloma following at least 1 prior therapy. The CD38-targeted antibody is accepted for use in combination with lenalidomide/dexamethasone or bortezomib/dexamethasone, according to Janssen, which is developing daratumumab with Genmab.

Survivors of acute myeloid leukemia (AML) produce antibodies that kill leukemia cells following allogeneic hematopoietic stem cell transplantation (HSCT) that can be used to treat other patients with AML.