US Food & Drug Administration grants Zydus Cadila tentative approval to market cancer drug

INDIA – Zydus Cadila has received tentative approval from the United States Food and Drug Administration (USFDA) to market Ibrutinib tablets used in the treatment of certain types of cancers.

The company will market Ibrutinib tablets, in the strengths of 140 mg, 280 mg, 420 mg and 560 mg in the US though it will be manufactured at the group’s formulation manufacturing facility at Ahmedabad.

Zydus Cadila now has 319 approvals and has so far filed over 400 abbreviated new drug applications (ANDAs) since the commencement of its filing process.

The tentative comes after Zydus Cadila received a lawsuit from Pharmacyclics LLC and Janssen Biotech for patent infringement.

Issues arose when Zydus, not the original developer of the drug, presented Ibrutinib to the USFDA seeking the approval to market it as a generic version of an Amendment to Abbreviated New Drug Application (ANDA).

About Ibrutinib

Imbruvica (ibrutinib) is a ground-breaking drug which covalently binds to a protein called Bruton’s tyrosine kinase (“BTK”), thereby irreversibly inhibiting BTK’s activity. The drug is the first BTK inhibitor drug approved by the FDA.

BTK is a key signaling molecule in the pathway that leads to B-cell growth and maturation following activation of the B-cell receptor. Abnormalities in the B-cell receptor signaling pathway can lead to uncontrolled cell growth and cause cancers of the blood and bone marrow.

Pharmacyclics partnered with Janssen to bring this revolutionary drug to patients across the United States and throughout the world. Janssen, recognizing the potential of the compound, invested hundreds of millions of dollars in the clinical development and commercialization of Imbruvica.

Initial clinical trials using Imbruvica to treat mantle cell lymphoma (“MCL”) showed that patients taking Imbruvica had an observed response rate of 68%.

These results led FDA to grant accelerated approval to Imbruvica for the treatment of MCL in patients who had received at least one prior therapy through the new Breakthrough Therapy Designation pathway.

Imbruvica was one of the first drugs ever to receive FDA approval via the Breakthrough Therapy Designation.

Imbruvica has one of the most robust clinical oncology development programs for a single molecule in the industry, with more than 130 ongoing clinical trials.

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