Biologic Immunotherapy for Bladder Cancer Receives FDA Advisory Hearing
October 5th 2015Telesta Therapeutics has been granted an FDA advisory hearing to discuss the biologics license application of its MCNA immunotherapy as treatment for high-risk nonmuscle invasive bladder cancer following first-line bacillus Calmette-Guerin (BCG).
Dabrafenib/Trametinib Improves Overall Survival in Advanced Melanoma
September 28th 2015Dabrafenib (Tafinlar), in combination with trametinib (Mekinist), improved overall survival (OS) by 7.6 months, compared to the single-agent vemurafenib (Zelboraf) in patients who have unresectable or metastatic BRAFV600E/K-mutant melanoma.
FDA Grants Priority Review to Carfilzomib for Relapsed Multiple Myeloma
September 21st 2015Carfilzomib (Kyprolis) in combination with dexamethasone, was recently granted a priority review designation by the FDA for patients who have relapsed multiple myeloma, following prior treatment with at least one therapy.
Supplemental New Drug Application Submitted for Frontline Ibrutinib in CLL
September 17th 2015AbbVie has submitted a supplemental new drug application for its BTK inhibitor ibrutinib (Imbruvica) as a therapy for treatment-naive patients with chronic lymphocytic leukemia (CLL) who are over the age of 65.
Ixazomib Granted Priority Review by the FDA for Multiple Myeloma
September 10th 2015Ixazomib (MLN9708), an oral proteasome inhibitor, was recently granted a priority review designation by the FDA, in combination with lenalidomide and dexamethasone for the treatment of patients who have relapsed and/or refractory multiple myeloma.
Intravesical Immunotherapy Priority Review for Bladder Cancer Granted by FDA
August 31st 2015A priority review designation was recently assigned by the FDA to the intravesical immunotherapy MCNA as a treatment for patients who have high-risk non-muscle invasive bladder cancer, following first-line bacillus Calmette-Guérin (BCG) therapy.
Hodgkin Lymphoma Label for Brentuximab Vedotin Expanded by FDA
August 18th 2015The antibody-drug conjugate (ADC) brentuximab vedotin (Adcetris) was recently approved by the FDA as a consolidation therapy following autologous stem cell transplantation (ASCT) in patients who have Hodgkin lymphoma and are at risk of relapse or progression.
FDA Delays Decision for Frontline Nivolumab
August 13th 2015The review period for frontline nivolumab (Opdivo), in patients who have advanced melanoma, recently received an extension of three months by the FDA, in order to allow ample time for review of the additional data submitted by Bristol-Myers Squibb (BMS)
New Trial Designs Hope to Improve the Discovery of Biomarkers in NSCLC
August 5th 2015Clinical trial designs are experiencing a huge transformation geared toward the discovery and confirmation of new predictive biomarkers for patients who have non-small cell lung cancer (NSCLC), as well as other types of solid tumors.
Rociletinib NDA Completed by Clovis Oncology for EGFR T790M-positive NSCLC
August 4th 2015A new drug application (NDA) was recently submitted for rociletinib (CO-1686) as a treatment for patients who have EGFR T790M-positive metastatic non-small cell lung cancer (NSCLC) following previous administration of an EGFR TKI.
Combinations of Checkpoint Inhibitors Under Investigation in NSCLC
August 4th 2015After a successful demonstration as single-agents, clinical trials are currently assessing PD-1 and PD-L1 inhibitors, combined with chemotherapy, targeted therapies, and radiation therapy, in an attempt to further improve outcomes for patients who have non-small cell lung cancer (NSCLC).
EC Approves Neoadjuvant Pertuzumab Regimen for HER2-Positive Early Breast Cancer
July 31st 2015Pertuzumab (Perjeta), in combination with trastuzumab (Herceptin) and chemotherapy, was approved by the European Commission (EC) as a neoadjuvant therapy for adult patients who have HER2-positive, locally advanced, inflammatory, or early stage breast cancer and are at high risk of recurrence.
Carfilzomib Phase III ENDEAVOR Data Submitted for FDA Approval in Myeloma
July 24th 2015A supplemental new drug application (sNDA) was recently submitted for carfilzomib (Kyprolis) in combination with dexamethasone for patients who have relapsed multiple myeloma, following previous treatment with at least one therapy.
Breakthrough Designation Granted to BRAF/MEK Combo for BRAF V600 NSCLC
July 23rd 2015Breakthrough therapy designation has been granted by the US Food and Drug Adminstration (FDA) to the combination of the BRAF inhibitor dabrafenib (Tafinlar) and the MEK inhibitor trametinib (Mekinist) as treatment for patients with BRAF V600E-mutant non–small cell lung cancer
Pembrolizumab (Keytruda) Approved by European Commission for Advanced Melanoma
July 23rd 2015The PD-1 inhibitor pembrolizumab (Keytruda) was recently approved by the European Commission for the treatment of adult patients who have unresectable or metastatic melanoma in the first-line and previously treated settings, based on data from three clinical trials that evaluated the medication in over 1500 patients.