FDA Gives Ribociclib Priority Review for Frontline HR+/HER2- Breast Cancer
November 2nd 2016The FDA has granted priority review designation to a new drug application for ribociclib for use in combination with letrozole as a frontline therapy for patients with HR–positive, HER2-negative advanced breast cancer.
Pembrolizumab Receives FDA Approval for Frontline PD-L1+ NSCLC Treatment
October 25th 2016Pembrolizumab (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.
FDA Updates Enzalutamide Label in mCRPC Based on New Study Findings
October 25th 2016The 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.
Olaratumab Receives FDA Approval for Soft Tissue Sarcoma
October 19th 2016The 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.
FDA Approves Atezolizumab for Lung Cancer Treatment
October 19th 2016Atezolizumab 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.
Study Findings Provide Latest Data on Neoadjuvant HER2+ Breast Cancer Treatment
October 14th 2016Results from the KRISTINE<sup> </sup>and NSABP B-41 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.
FDA Panel Votes 14-0 Against Approval of Apaziquone for Bladder Cancer
October 5th 2016In 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.
EMA Validation Puts Nivolumab Under Formal Review for Bladder Cancer
October 5th 2016A 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.
Metformin Shows Positive Results in Endometrial Cancer
September 26th 2016Findings 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.
Ceritinib Improves Progression-Free Survival in ALK+ NSCLC
September 26th 2016According 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)
CHMP Recommends Approval of Olaratumab Combo for Soft Tissue Sarcoma
September 22nd 2016The 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.
Pembrolizumab Receives Priority Review From FDA for NSCLC
September 8th 2016Merck, 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 Receives FDA Approval for Acute Lymphoblastic Leukemia
September 8th 2016Blinatumomab (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).
EMA Validation Puts Neratinib One Step Closer to Approval for HER2+ Breast Cancer
September 2nd 2016<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 Shows Potential in Advanced Thyroid Cancer
August 31st 2016Pembrolizumab (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).
Rucaparib Granted Priority Review for Ovarian Cancer
August 24th 2016Priority 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.
Extended-Release of Granisetron for CINV Now Approved
August 12th 2016The 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.