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FDA Breakthrough Therapy Designation: 29, 30 And Counting

January 14, 2014

FDA Breakthrough Therapy Designation #29

On January 13, GlaxoSmithKline (GSK) announces that Tafinlar (Dabrafenib) receives the coveted FDA Breakthrough Therapy Designation (BTD) for metastatic BRAF V600E mutation-positive Non-Small Cell Lung Cancer (NSCLC) for patients who have at least one prior line of platinum-containing chemotherapy. Tafinlar is currently approved for Melanoma. This is the 29th BTD that is announced by a sponsor company.

This is the 4th FDA BTD that GSK receives :

Row Num

Drug Name

Sponsor                       Company Indication


Drisapersen GSK Duchenne   MuscularDystrophy


Ofatumumab Genmab/GSK Chronic   LymphocyticLeukemia (CLL)


Tafenoquine GSK/Medicines for Malaria   Venture Plasmodium Vivax     Malaria


Dabrafenib GSK Metastatic BRAF V600E Mutation-Positive Non-Small Cell Lung Cancer   (NSCLC)


The BTD is granted based on interim results from an ongoing Phase II study of Dabrafenib given orally to 25 patients with BRAF V600E NSCLC, who had at least one course of previous chemotherapy. These interim results are presented at the 2013 American Society for Clinical Oncology (ASCO) Annual Meeting.

FDA Breakthrough Therapy Designation #30

Gilead Sciences announces on January 13, that the FDA accepts for review the New Drug Application (NDA) for Idelalisib for refractory Indolent Non-Hodgkin’s Lymphoma (iNHL) with a PDUFA date of September 11, 2014. The NDA for iNHL is submitted on September 11, 2013.

Following the NDA submission on September 11, 2013 for iNHL, the FDA grants Idelalisib the BTD for relapsed Chronic Lymphocytic Leukemia (CLL). Gilead Sciences submits an NDA for Idelalisib for the treatment of CLL on December 6, 2013. This is the 30th BTD that is announced by a sponsor company. Gilead files for approval for Idelalisib for both iNHL and CLL with the European Medicines Agency (EMA) on October 28, 2013.

This is the 2nd FDA BTD that Gilead Sciences receives :

Row Num

Drug Name



Sofosbuvir Hepatitis C


Idelalisib Relapsed Chronic LymphocyticLeukemia (CLL)

Sovaldi (Sofosbuvir) receives FDA approval in December 2013.

Please Note: FDA Official Logo from FDA website.

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