GlaxoSmithKline plc received FDA Breakthrough Therapy designation for its Tafinlar® (dabrafenib)

Marks GSK’s fourth Breakthrough Therapy designation

London, UK, 17-1-2014 — /EuropaWire/ —  GlaxoSmithKline plc (LSE: GSK) announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Tafinlar^®(dabrafenib) for treatment of patients with metastatic BRAF V600E mutation-positive non-small cell lung cancer (NSCLC) who have received at least one prior line of platinum-containing chemotherapy.  Dabrafenib is not approved or licensed anywhere in the world for use in this treatment setting.

The Breakthrough Therapy designation was based on interim efficacy and safety results from an ongoing Phase II study of dabrafenib administered orally to 25 patients who had NSCLC with the BRAF V600E mutation and who had received at least one previous course of chemotherapy. These interim results were presented at the 2013 American Society for Clinical Oncology Annual Meeting.

Lung cancer is the second most common cancer in both men and women and is by far the leading cause of cancer-related death worldwide. Recent advances in the understanding of tumour biology have identified genetic mutations, such as mutation in the BRAF protein, that can drive malignant cell growth and tumour proliferation in NSCLC. It is estimated that the BRAF V600E mutation targeted by dabrafenib is present in approximately 2.0%.[i], [ii] of patients with NSCLC.

About Breakthrough Therapy Designation
The Breakthrough Therapy designation was enacted as part of the 2012 FDA Safety and Innovation Act and is intended to expedite development and review of drugs to treat serious or life-threatening medical conditions when preliminary clinical evidence demonstrates that the drug may have substantial improvement on at least one clinically significant endpoint over available therapies.

Breakthrough Therapy designation includes all the features of the Fast Track designation, as well as more intensive guidance from the FDA on a drug’s clinical development program.

For full US Prescribing Information and Medication Guide and EU Patient Information Leaflet or Summary of Product Characteristics (SPC) for Tafinlar^® please visit http://www.gsk.com/products.html

GSK – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com.

GSK enquiries:
UK Media enquiries: David Mawdsley +44 (0) 20 8047 5502 (London)
Simon Steel +44 (0) 20 8047 5502 (London)
David Daley +44 (0) 20 8047 5502 (London)
Catherine Hartley +44 (0) 20 8047 5502 (London)

US Media enquiries: Melinda Stubbee +1 919 483 2510 (North Carolina)
Catalina Loveman +1 215 751 4958 (Philadelphia)
Anna Padula +1 215 751 4271 (Philadelphia)
Karen Collins +1 919 483 2527 (North Carolina)
Stephen Rea +1 215 751 4394 (Philadelphia)

Analyst/Investor enquiries: Sally Jackson +44 (0) 20 8047 5543 (London)
Kirsty Collins (SRI & CG) +44 (0) 20 8047 5534 (London)
Tom Curry + 1 215 751 5419 (Philadelphia)
Gary Davies +44 (0) 20 8047 5503 (London)
James Dodwell +44 (0) 20 8047 2406 (London)
Jeff McLaughlin +1 215 751 7002 (Philadelphia)
Ziba Shamsi +44 (0) 20 8047 3289 (London)
Lucy Singah +44 (0) 20 8047 2248

Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK’ s operations are described under Item 3.D ‘Risk factors’ in the company’s Annual Report on Form 20-F for 2012.

References:

[i] Cardarella S, Ogino A, Nshino M. Clin Cancer Res 2013;19:4532-4540

[ii] Marchetti A, Felicioni L, Malatesta S, et. al. J Clin Oncol 2011;29: 3574-3579