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Update on European application for Keytruda in combination with Pemetrexed and Carboplatin for first-line treatment of nonsquamous non-small cell lung cancer

Merck ( MSD ) has withdrawn its European application for Keytruda ( Pembrolizumab ) in combination with Pemetrexed and Carboplatin as a first-line treatment for metastatic nonsquamous non-small cell l ... read article

Nivolumab in glioblastoma multiforme, CheckMate -143 did not meet its primary endpoint of improved overall survival

CheckMate -143, a randomized phase 3 clinical trial evaluating the efficacy and safety of Nivolumab ( Opdivo ) in patients with first recurrence of glioblastoma multiforme ( GBM ), did not meet its pr ... read article

Nivolumab in glioblastoma multiforme, CheckMate -143 did not meet its primary endpoint of improved overall survival

Keytruda in recurrent or metastatic head and neck cancer, FDA granted priority review

The FDA ( Food and Drug Administration ) has accepted for review the supplemental Biologics License Application ( sBLA ) for Keytruda ( Pembrolizumab ), an anti-PD-1 therapy, for the treatment of pati ... read article

Advanced melanoma: a combination of two immunotherapeutic agents, Opdivo and Yervoy, has received positive CHMP opinion

The Committee for Medicinal Products for Human Use ( CHMP ) of the EMA ( European Medicines Agency ) has recommended the approval of Opdivo ( Nivolumab ) in combination with Yervoy ( Ipilimumab ) for ... read article

Advanced melanoma: Pembrolizumab, an immunoinhibitory checkpoint protein

Pembrolizumab ( Keytruda ) is a humanized monoclonal antibody against programmed death receptor-1 ( PD-1 ), a key immunoinhibitory checkpoint protein implicated in down-regulating anti-tumour immune r ... read article

PI3K/mTOR pathway as a potential therapeutic target for melanoma intrinsically resistant to BRAF inhibitors

Dysregulation of receptor tyrosine kinases ( RTKs ) contributes to several aspects of oncogenesis including drug resistance. In melanoma, distinct RTKs have been involved in BRAF inhibitors ( BRAFi ) ... read article

Selumetinib, a MEK inhibitor, in combination with Dacarbazine does not effective in uveal melanoma

The phase 3 SUMIT study of Selumetinib in combination with Dacarbazine for the treatment of patients with metastatic uveal melanoma did not meet its primary endpoint of progression free survival. Th ... read article

Cobimetinib in combination with Vemurafenib in patients with BRAF V600 mutation-positive advanced melanoma

Positive overall survival results from coBRIM, the phase 3 pivotal trial evaluating Cobimetinib, a specific MEK inhibitor, in combination with Vemurafenib in previously untreated patients with unresec ... read article

Advanced melanoma: positive CHMP opinion for Keytruda

The CHMP ( Committee for Medicinal Products for Human Use ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Keytruda, intended as monot ... read article

Keytruda, an anti-PD-1 therapy, in advanced non-small cell lung cancer

The supplemental Biologics License Application ( sBLA ) for anti-PD-1 therapy, Keytruda ( Pembrolizumab ), for the treatment of patients with advanced non-small cell lung cancer ( NSCLC ) whose diseas ... read article

Combination of Mekinist and Tafinlar for unresectable or metastatic melanoma with BRAF V600E or V600K mutations, approved by FDA

The FDA ( Food and Drug Administration ) has approved Mekinist ( Trametinib ) for use in combination with Tafinlar ( Dabrafenib ) for the treatment of patients with unresectable melanoma or metastatic ... read article

Positive results of phase 3 Talimogene Laherparepvec trial in melanoma

Amgen has announced top-line results from the phase 3 trial in melanoma, which has evaluated the efficacy and safety of Talimogene Laherparepvec for the treatment of unresected stage IIIB, IIIC or IV ... read article

PLX4032: preliminary phase 2 data in metastatic melanoma

Preliminary data from a pivotal Phase 2 clinical trial of PLX4032 ( RG7204 ) in metastatic melanoma, have shown significant tumor shrinkage in the majority of patients. These results support previousl ... read article

Belimumab: safety findings

The safety database for Belimumab ( Benlysta ) is based primarily on the three randomized, placebo-controlled studies ( L02, C1056, and C1057 ) and their safety extensions. Death There were a to ... read article

Focus

Multiple sclerosis: FDA has approved Tecfidera

The FDA ( Food and Drug Administration ) has approved Tecfidera ( Dimethyl fumarate ) capsules to treat adults with relapsing forms of multiple sclerosis.Multiple sclerosis is a chronic, inflammatory, ... read article

Apremilast linked to significant and clinically meaningful improvements for the primary and major secondary endpoint in plaque psoriasis

Celgene has announced that statistical significance for the primary endpoint of PASI 75 at week 16 was achieved for patients receiving Apremilast 30 mg BID monotherapy in both the ESTEEM 1 and 2 phase ... read article

Kadcyla, a new treatment for late-stage breast cancer, approved by Food and Drug Administration

The U.S. Food and Drug Administration ) has approved Kadcyla ( Ado-Trastuzumab Emtansine ), a new therapy for patients with HER2-positive, late-stage ( metastatic ) breast cancer.HER2 is a protein inv ... read article

FISSION and NEUTRINO trial: Sofosbuvir has met primary endpoints for hepatitis C

Results from two Phase 3 studies, FISSION and NEUTRINO, evaluating a 12-week course of the once-daily nucleotide Sofosbuvir in combination with Ribavirin ( FISSION ) and in combination with Ribavirin ... read article

FDA has approved Eliquis to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation

The FDA ( Food and Drug Administration ) has approved the anti-clotting drug Eliquis ( Apixaban ), an oral tablet used to reduce the risk of stroke and dangerous blood clots ( systemic embolism ) in p ... read article

Chronic hepatitis C: Promacta for patients with thrombocytopenia to allow the initiation and maintenance of Interferon-based therapy

GlaxoSmithKline ( GSK ) has announced that the FDA ( Food and Drug Administration ) has approved Promacta ( Eltrombopag; in Europe: Revolade ) for the treatment of thrombocytopenia in patients with ch ... read article

Bosulif for chronic myelogenous leukemia, approved by Food and Drug Administration

The FDA ( Food and Drug Administration ) has approved Bosulif ( Bosutinib ) to treat chronic myelogenous leukemia ( CML ), a blood and bone marrow disease that usually affects older adults.An estimate ... read article

Increased risk of high-grade prostate cancer with 5-alpha reductase inhibitors

Men aged 55 and over with a normal digital rectal examination and PSA less than or equal to 3.0 ng/mL at baseline taking Finasteride 5 mg/day ( 5 times the dose of Propecia ) in the 7-year Prostate Ca ... read article