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FDA Breakthrough Therapy Designation: Roche Receives #24

September 25, 2013

Roche announces on September 23, 2013, that the FDA grants non-orphan drug Alectinib the coveted Breakthrough Therapy Designation (BTD). Alectinib, an ALK inhibitor, is being evaluated for the treatment of patients with Anaplastic Lymphoma Kinase positive (ALK+) Non-Small Cell Lung Cancer (NSCLC).

The FDA BTD is based on data that is to be presented at the European Cancer Congress (ECC), Septembr 27 –  October 1, 2013, in Amsterdam.  At ECC, the following Abstract will be presented on September 30 in the Proffered Papers Session :

Abstract #44: Safety and efficacy analysis of RO5424802/CH5424802 in anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) patients who have failed crizotinib in a dose-finding phase I study (AF-002JG, NCT01588028).

Some Observations

•   This is the 2nd BTD for Roche (Novartis has 3 BTDs & J&J/ Pharmacyclics has 3 BTDs for Ibrutinib for 3 cancer indications) :

Row Num

Drug Name

Sponsor              Company Indication
13

Obinutuzumab

Genentech Chronic LymphocyticLeukemia(CLL)
24

Alectinib

Roche ALK+     Non-Small Cell Lung Cancer(NSCLC)

Note: Genentech is a member of the Roche Group.

•   Alectinib’s BTD is for a cancer indication – approximately 50% of the BTDs currently identified by a sponsor company are for a cancer indication
•   2 BTDs are for the indication of ALK+ NSCLC :

Row Num

Drug Name

Sponsor              Company Indication
8

LDK378

Novartis ALK+ Non-SmallCell LungCancer (NSCLC)
24

Alectinib

Roche ALK+     Non-Small Cell Lung Cancer(NSCLC)

•   UK’s National Institute for Health and Care Excellence (NICE) rejects Pfizer’s Xalkori (Crizotinib) for previously treated ALK+ advanced NSCLC.

Please Note: “A group of three balloons on ribbons” JPEG by AJ (Open clip Art Library image’s page) [see page for license] | Wikimedia Commons.

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