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FDA Breakthrough Therapy Designation: FDA Approval Of Amgen’s Cancer Immunotherapy Blincyto For ALL

December 5, 2014

The FDA announces December 3rd, the approval of Amgen’s cancer immunotherapy Blincyto (Blinatumomab), for Philadelphia chromosome-negative precursor B-cell Acute Lymphoblastic Leukemia (B-cell ALL). Blincyto receives FDA Breakthrough Therapy Designation (BTD – July 2014), priority review, and Orphan Drug Designation (ODD – May 2008). The drug is approved (> 5 months before PDUFA date of May 19, 2015) under the FDA’s accelerated approval program with REMS (Risk Evaluation and Mitigation Strategy). The FDA is requiring Amgen to conduct a study verifying that the drug improves survival for relapsed or refractory Philadelphia-negative precursor B-cell ALL.   

Per the FDA Press Release:

“Blincyto is an example of immunotherapy, a treatment that uses certain parts of a person’s immune system to fight diseases such as cancer. Blincyto is the first approved drug that engages the body’s T-cells, a type of white blood cell or lymphocyte, to destroy leukemia cells. The drug acts as a connector between a protein called CD19, which is found on the surface of most B-cell lymphoblasts, and CD3, a protein on T-cell lymphocytes. It is intended for patients whose cancer returned after treatment (relapsed) or did not respond to previous treatment (refractory).”

FDA CBER BTDs Receiving Approval (as of 10/29/14)

The FDA CBER Breakthrough Therapy Designations receiving approval (as of 10/29/14), in ascending chronological “FDA Approval Date” order, are as follows:

Drug Name FDA Approval Date Sponsor Company Indication
Trumenba (Meningococcal Group B Vaccine) ***** 10.29.14 Pfizer Meningococcal B Disease

***** Accelerated Approval.

FDA CDER BTDs Receiving Approval (as of 12/03/14)

The FDA CDER Breakthrough Therapy Designations receiving approval (as of 12/04/14), in ascending chronological “FDA Approval Date” order, are as follows:

Drug Name FDA Approval Date Sponsor Company Indication
Gazyva   (Obinutuzumab) 11.01.13 Genentech Chronic Lymphocytic Leukemia (CLL)
Imbruvica   (Ibrutinib) 11.13.13 Pharmacyclics Mantle Cell Lymphoma (MCL)
Sovaldi   (Sofosbuvir) 12.06.13 Gilead   Sciences Hepatitis C
Kalydeco (Ivacaftor)** 02.21.14 Vertex Pharmaceuticals 8 additional mutations in CFTR gene for Cystic Fibrosis (CF)
Arzerra (Ofatumumab) *** 04.17.14 GlaxoSmithKline In combination with Chlorambucil for previously untreated Patients with CLL for whom fludarabine-based therapy is considered inappropriate
Zykadia (Ceritinib) 04.29.14 Novartis Metastatic ALK+ NSCLC
Zydelig (Idelalisib) 07.23.14 Gilead Sciences Chronic Lymphocytic Leukemia (CLL)
Imbruvica (Ibrutinib)* 07.28.14 Pharmacyclics Chronic Lymphocytic Leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion)
Promacta (Eltrombopag)** 08.26.14 GlaxoSmithKline Severe Aplastic Anemia (SAA) with insufficient response to Immunosupporessive Therapy (IST)
Keytruda (Pembrolizumab) **** 09.04.14 Merck Unresectable/ Metastatic Melanoma, disease progression, & have BRAF V600 mutation, following treatment with Yervoy & a BRAF inhibitor
Harvoni (Ledipasvir /Sofosbuvir) 10.10.14 Gilead Sciences Genotype 1 Chronic HCV
Esbriet (Pirfenidone) 10.15.14 InterMune Idiopathic Pulmonary Fibrosis
Ofev (Nintedanib) 10.15.14 Boehringer Ingelheim Pharmaceuticals Idiopathic Pulmonary Fibrosis
Blincyto (Blinatumomab) ***** 12.03.14 Amgen Philadelphia chromosome-negative precursor B-cell Acute Lymphoblastic Leukemia (B-cell ALL)

* 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)

**** Pembrolizumab formerly known as Lambrolizumab

***** Accelerated Approval.

References

FDA BTD Chart

FDA BTD Approval Chart

FDA BTD Statistics Chart.

Please Note: FDA Official Logo from FDA website.

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

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