List view / Grid view

News

Eisai bewildered as IQWIG fails to recognise OS benefit of liposarcoma drug

5 September 2016 | By Niamh Louise Marriott, Digital Content Producer

n study 309, the pivotal phase III trial on which the indication approval was based, eribulin demonstrated a significant survival advantage in advanced liposarcoma; patients treated with eribulin compared to those treated with dacarbazine, a longstanding, established and internationally accepted treatment option, benefited from a median 7.2 month increase in…

Destiny’s SA trial shows fast acting antibiotic too quick for disease resistance

5 September 2016 | By Niamh Louise Marriott, Digital Content Producer

The two-stage clinical trial studied the safety, tolerability, and efficacy of intra-nasally applied exeporfinium chloride gels. Part 1 yielded safety data in eight volunteers and allowed progression to Part 2 in 48 healthy volunteers with colonised nasal Staphylococcus aureus (SA) bacteria. Part 2 was double-blinded, placebo controlled, and investigated two…

Roche’s cancer immunotherapy drug has longer OS vs. chemotherapy

1 September 2016 | By Niamh Louise Marriott, Digital Content Producer

Roche’s study for tecentriq (atezolizumab) met its co-primary endpoints and showed a statistically significant and clinically meaningful improvement in overall survival (OS) compared with docetaxel chemotherapy in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed on or after treatment with platinum-based chemotherapy. Adverse events…

FDA approves Novartis’ biosimilar to treat multiple inflammatory diseases

1 September 2016 | By Niamh Louise Marriott, Digital Content Producer

The FDA approval is based on analytical, nonclinical, and clinical data confirming that Erelzi is highly similar to the US-licensed reference product. Clinical studies included four comparative pharmacokinetic (PK) studies in 216 healthy volunteers and a confirmatory efficacy and safety similarity study in 531 patients with chronic plaque psoriasis...

EU approval for Pfizer’s non-small cell lung cancer drug

1 September 2016 | By Niamh Louise Marriott, Digital Content Producer

The drug exhibited marked anti-tumour activity in patients with ROS1-positive advanced NSCLC and met its primary endpoint of ORR. Tumours were tested for ROS1 rearrangements by laboratory-developed break-apart fluorescence in situ hybridization (FISH) (96%) or real-time polymerase chain reaction (RT-PCR) (4%) assay...

FDA approves Genmab’s ofatumumab for relapsed CLL

31 August 2016 | By Niamh Louise Marriott, Digital Content Producer

Approval is supported by the Phase III complement study that evaluated ofatumumab in combination with FC versus FC alone in patients with relapsed CLL...