Skip Navigation LinksHome > Blogs > FDA Actions & Updates
FDA Actions & Updates

The latest approvals, designations, and new indications from the U.S. Food and Drug Administration for oncology drugs.

Monday, May 18, 2015

The U.S. Food and Drug Administration has granted Fast Track designation to AG-120 for the treatment of patients with acute myelogenous leukemia with an isocitrate dehydrogenase-1 (IDH1) mutation. AD-120 is a first-in-class, oral, selective, potent inhibitor of the mutated IDH1 protein.

 

The Fast Track designation, established under the FDA Modernization Act of 1997, is designed to facilitate frequent interactions with the FDA review team to expedite clinical development and submission of a New Drug Application for medicines with the potential to treat serious or life-threatening conditions and address unmet medical needs. The designation permits the drug developer the opportunity to submit sections of an NDA on a rolling basis as data become available, allowing the FDA to review those materials on a rolling basis as well.

 

The drug is currently being evaluated in a Phase I clinical trial for this indication and results are expected to be presented at the European Hematology Association Annual Congress in June, according to a news release from the drug company, Agios Pharmaceuticals. A Phase III study to evaluate the drug for this indication is being planned to begin in 2016.


Monday, May 18, 2015

The U.S. Food and Drug Administration has granted orphan drug designation to GMI-1271 for use in combination with chemotherapy for the treatment of patients with acute myeloid leukemia (AML). GMI-1271 is a novel and proprietary E-selectin antagonist that increases the ability of chemotherapy to kill cancer cells.

 

The Orphan Drug designation—to encourage development of drugs in the diagnosis, prevention, or treatment of a medical condition affecting fewer than 200,000 people in the U.S.—grants a product market exclusivity for a seven-year period if the sponsor complies with certain FDA specifications, as well as tax credits and prescription drug user fee waivers. The designation does not, though, shorten the duration of the regulatory review and approval process.

 

Approximately 20,830 individuals in the U.S. will be diagnosed with AML this year, and 10,460 will die from the disease, according to estimates from the American Cancer Society.

 

An open-label, multicenter Phase I/II study to evaluate the safety, pharmacokinetics, and efficacy of GMI-1271 used in combination with chemotherapy for the treatment of adult patients with AML is currently recruiting patients. Preclinical data supporting use of the drug were presented at the 2013 American Society of Hematology Annual Meeting.


Friday, May 15, 2015

The U.S. Food and Drug Administration has granted Fast Track designation to sacituzumab govitecan for the treatment of patients with metastatic non-small cell lung cancer that has failed to respond to two prior lines of therapy, including targeting therapies such as ALK inhibitors, EFGR inhibitors, and PD-1 inhibitors. Sacituzumab govitecan is an antibody-drug conjugate that works by conjugating SN-38, the active metabolite of irinotecan (Camptosar).

 

The Fast Track designation, established under the FDA Modernization Act of 1997, is designed to facilitate frequent interactions with the FDA review team to expedite clinical development and submission of a New Drug Application for medicines with the potential to treat serious or life-threatening conditions and address unmet medical needs. The designation permits the drug developer the opportunity to submit sections of an NDA on a rolling basis as data become available, allowing the FDA to review those materials on a rolling basis as well.

 

Updated results of the current clinical trial for the drug will be reported at the American Society of Clinical Oncology Annual Meeting later this month, according to a news release from the drug company, Immunomedics, Inc.

 

The FDA has previously granted Fast Track status to sacituzumab govitecan for the treatment of patients with triple-negative breast or small-cell lung cancers; and the drug has received orphan drug designation for the treatment of patients with small-cell lung or pancreatic cancers (OT 2/10/15 issue).


Wednesday, May 13, 2015

The U.S. Food and Drug Administration has granted Fast Track designation to evofosfamide (previously TH-302) for use in combination with gemcitabine for the treatment of patients with previously untreated metastatic or locally advanced resectable pancreatic cancer. Evofosfamide is an investigational hypoxia-activated prodrug thought to be activated under the severe tumor hypoxic conditions typical of many solid tumors. The drug is currently in Phase III trials for this indication.

 

The Fast Track designation, established under the FDA Modernization Act of 1997, is designed to facilitate frequent interactions with the FDA review team to expedite clinical development and submission of a New Drug Application for medicines with the potential to treat serious or life-threatening conditions and address unmet medical needs. The designation permits the drug developer the opportunity to submit sections of an NDA on a rolling basis as data become available, allowing the FDA to review those materials on a rolling basis as well.

 

The drug has also previously received Fast Track designation for use in combination with doxorubicin for the treatment of advanced soft tissue sarcoma (2014).

 

Evofasmide is being developed by Merck in collaboration with Threshold Pharmaceuticals, Inc.


Monday, May 11, 2015

The U.S. Food and Drug Administration has approved the Cobas KRAS Mutation Test for diagnostic use to identify KRAS mutations in tumor samples from patients with metastatic colorectal cancer (mCRC) to help clinicians determine the best therapy. The test is a TaqMelt assay, which is a polymerase chain reaction (PCR)-based diagnostic test intended for the detection of mutations in codons 12 and 13 of the KRAS gene.

 

The test can be performed in less than eight hours; and it is intended to be used as an aid in the identification of patients with mCRC for whom treatment with cetuximab (Erbitux) or panitumumab (Vectibix) may be effective if no KRAS mutation is present.

 

The test is performed using the Cobas 4800 System, which is also used for performing the Cobas BRAF V600 Mutation Test (approved in 2011, OT 9/10/11 issue) and the Cobas EGFR Mutation Test (approved in 2013, OT 6/10/13 issue). All three tests are marketed by Roche.

 

Twitter Facebook LinkedIn
Blogs Archive