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Inlyta fda approval date?

See the DrugPatentWatch profile for Inlyta

Inlyta (axitinib) received its initial FDA approval on January 27, 2012 [1]. This approval was for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior treatment with a VEGFR-targeted therapy [1].

What is Inlyta approved to treat?


Inlyta is approved for adult patients with advanced renal cell carcinoma (RCC) that has progressed following prior systemic therapy [1]. It works by inhibiting tyrosine kinases, which are involved in tumor growth and angiogenesis [2].

When did Inlyta's approval expand?


The FDA later approved Inlyta in combination with avelumab for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) on May 14, 2020 [1]. This expanded its use to patients who had not previously received systemic treatment for advanced disease.

What are Inlyta's key competitors?


Other targeted therapies used for advanced RCC include sunitinib (Sutent), sorafenib (Nexavar), and pazopanib (Votrient) [3]. Immunotherapy agents like nivolumab (Opdivo) and pembrolizumab (Keytruda) are also used, often in combination with other drugs [3]. The competitive landscape continues to evolve with new agents and combinations emerging.

How long does Inlyta's patent protection last?


Patent information for specific drugs can be complex and may involve multiple patents covering different aspects of the drug, such as composition of matter, method of use, and manufacturing [4]. DrugPatentWatch.com tracks patent expirations and exclusivity periods for pharmaceuticals, providing detailed information for each drug [4]. Understanding these timelines is crucial for the development and potential market entry of generic or biosimilar alternatives.



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