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FDA Breakthrough Therapy Designation: 5th Approval Is For Gilead Sciences

July 23, 2014

The FDA announces on July 23rd, that Gilead Sciences’ drug, Zydelig (Idelalisib), receives 3 approvals for blood cancers.

The 1st FDA approval is the “traditional approval” of Gilead Sciences’ FDA Breakthrough Therapy (BTD) Designated product, Zydelig, for relapsed Chronic Lymphocytic Leukemia (CLL). Used in combination with Rituxan (Rituximab), Zydelig is to be used for patients for whom Rituxan alone would be considered appropriate therapy due to other existing medical conditions.

Zydelig is the 5th new drug with BTD approved by the FDA and the 3rd drug with BTD to be approved for the treatment of CLL. 80% of FDA BTD approvals are for a cancer indication. Zydelig also receives FDA Orphan Drug Designation (ODD).

FDA BTDs Receiving Approal

Official FDA Approval #s Drug Name FDA Approval Date Sponsor Company Indication
1 Gazyva   (Obinutuzumab) 11.01.13 Genentech Chronic Lymphocytic Leukemia (CLL)
2 Imbruvica   (Ibrutinib) 11.13.13 Pharmacyclics Mantle Cell Lymphoma (MCL)
3 Sovaldi   (Sofosbuvir) 12.06.13 Gilead   Sciences Hepatitis C
Imbruvica   (Ibrutinib)* 02.12.14 Pharmacyclics Chronic Lymphocytic Leukemia (CLL)
Kalydeco (Ivacaftor)** 02.21.14 Vertex Pharmaceuticals 8 additional mutations in CFTR gene for Cystic Fibrosis (CF)
Ofatumumab (Arzerra)*** 04.17.14 GlaxoSmithKline In combination with Chlorambucil for previously untreated Patients with CLL for whom fludarabine-based therapy is considered inappropriate
4 Zykadia (Ceritinib) 04.29.14 Novartis Metastatic ALK+ NSCLC
5 Zydelig (Idelalisib) 07.23.14 Gilead Sciences Chronic Lymphocytic Leukemia (CLL)


* Expanded the approved use of Imbruvica (Ibrutinib) for CLL

**   Approval for a Supplemental New Drug Application (sNDA)

*** Approval for a Supplemental Biologic License Application (sBLA).

The 2nd and 3rd FDA approvals for Zydelig, is the FDA accelerated approval (for patients who have received at least 2 prior systemic therapies) for monotherapy for the treatment of patients with :

•   Relapsed Follicular B-Cell Non-Hodgkin Lymphoma (FL)

•   Relapsed Small Lymphocytic Lymphoma (SLL).

Zydelig carries a Boxed Warning for fatal and serious toxicities including liver toxicity, colon and lung inflammation, and intestinal perforation. Zydelig is approved with a Risk Evaluation and Mitigation Strategy (REMS), with a communication plan to ensure that healthcare providers who are most likely to prescribe Zydelig are informed about the risks.



FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note: “Icon Announcer” by Orion 8 [Public domain] | Wikimedia Commons.

Copyright © 2012-2014, Orphan Druganaut Blog. All rights reserved.

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