In a 14-0 vote, the FDA’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 trial<sup>1 </sup>showed that combining 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–small cell lung cancer (NSCLC)
Bruce Cheson, MD, outlines the treatment choices for each of the 3 patient categories of CLL, noting that, regardless of the treatment, “a clinical trial is always the preferred option.”
The PDGFRα antagonist olaratumab has been recommended approval by The Committee for Medicinal Products for Human Use (CHMP) 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 <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.
Final data from a phase III trial of CPX-351 (Vyxeos) in older patients with high-risk, secondary acute myeloid leukemia (AML) revealed that CPX-351 reduced the mortality risk by 31% compared with cytarabine and daunorubicin (7+3), according to findings presented at the 2016 ASCO Annual Meeting.
The FDA has granted nivolumab a breakthrough therapy designation for the treatment of patients with resectable locally advanced or metastatic urothelial carcinoma after the failure of a platinum-containing regimen.
Sunitinib extended disease-free survival versus placebo as an adjuvant therapy for patients with renal cell carcinoma at high risk of recurrence in the phase III S-TRAC trial.
A number of small changes that were specific to neoadjuvant and adjuvant therapies were made to the NCCN breast cancer guidelines, additionally, the recommended treatments for patients with ER-positive disease were also modified.
Nivolumab (Opdivo) treatment provided antitumor responses in patients with microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC), whether given as a single agent or in combination with ipilimumab (Yervoy). Interim data from the phase II CheckMate-142 trial was presented at the 2016 ASCO Annual Meeting.
Palbociclib (Ibrance), when added to letrozole, increased the median progression-free survival (PFS) rate in patients with ER-positive, HER2-negative advanced or metastatic breast cancer by >10 months, according to results from the phase III PALOMA-2 trial presented at the 2016 ASCO Annual Meeting.
When tested in heavily pretreated patients with refractory, hormone-receptor (HR)-positive, HER2-negative advanced breast cancer, abemaciclib, a CDK4/6 inhibitor, produced a positive response rate of approximately 20%.
A majority of patients (66%) with classical Hodgkin lymphoma (cHL) who had progressed after receiving autologous stem cell transplant (ASCT) and brentuximab vedotin (adcetris) experienced a response to nivolumab (Opdivo) monotherapy, findings from the phase II CheckMate-205 trial showed when presented at the 2016 ASCO Annual Meeting.
Combination therapy nivolumab (Opdivo) and ipilimumab (Yervoy) resulted in reduced disease progression risk of 58% when compared with ipilimumab alone in patients with advanced melanoma. Additionally, nivolumab monotherapy showed greater risk reduction (45%) compared with ipilimumab single-agent treatment.
Combining PD-L1 inhibitor atezolizumab with investigational OX40 agonist MOXR0916 treatment showed early signs of antitumor activity in solid tumor types and was well tolerated by patients.
Updated findings from the phase III CheckMate-057 and -017 trials showed sustained improvements in overall survival (OS) data of nivolumab (Opdivo) treatment in pretreated patients with nonsquamous or squamous non-small cell lung cancer (NSCLC).
Survival outcomes in patients with KRAS wild-type metastatic colorectal cancer (mCRC) were significantly longer among those with tumors originating on the left versus the right side of the colon, according to a retrospective analysis of the phase III 80405 trial.