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Date: 2012-01-30

Type of information: Granting of a Market Authorisation in the EU

Product name: Inlyta®

Compound: axitinib

Therapeutic area: Cancer - Oncology

Action mechanism:

tyrosine kinase inhibitor/VEGFR inhibitor. Axitinib is an oral and selective inhibitor of vascular endothelial growth factor receptors (VEGFR) 1, 2, and 3.

Company: Pfizer (USA - NY)

Disease:

advanced renal cell carcinoma

Latest news:

* On June 1, 2011, Pfizer Inc. announced that the European Medicines Agency (EMA) has accepted Pfizer’s filing for regulatory review of axitinib for patients with advanced renal cell carcinoma (RCC) after failure of prior systemic treatment. This submission was based on Phase 3 data from the AXIS 1032 trial.

* On January 27, 2012, FDA approved Inlyta® (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer.
The safety and effectiveness of Inlyta® were evaluated in a single randomized, open-label, multi-center clinical study of 723 patients whose disease had progressed on or after treatment with one prior systemic therapy. The study was designed to measure progression-free survival, the time a patient lived without the cancer progressing. Results showed a median progression-free survival of 6.7 months compared to 4.7 months with a standard treatment (sorafenib). The most common side effects observed in greater than 20 percent of patients in the clinical study were diarrhea, high blood pressure (hypertension), fatigue, decreased appetite, nausea, loss of voice (dysphonia), hand-foot syndrome (palmar-plantar erythrodysesthesia), weight loss, vomiting, weakness (asthenia) and constipation. Patients with high blood pressure should have it well-controlled before taking Inlyta®. Some patients who took Inlyta experienced bleeding problems, which in some cases were fatal. Patients with untreated brain tumors or gastrointestinal bleeding should not take Inlyta. Recently approved drugs for the treatment of kidney cancer include sorafenib (2005), sunitinib (2006), temsirolimus (2007), everolimus (2009), bevacizumab (2009) and pazopanib (2009).

* On 24 May 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Inlyta®, 1 mg and 5 mg film-coated tablets, intended for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.
The benefits with Inlyta® are its ability to delay the progression of disease in patients previously treated with sunitinib and its ability to improve the survival and to delay the progression of disease in patients previously treated with cytokines. The most common side effects are diarrhoea, hypertension, fatigue, dysphonia, nausea, decreased appetite, and palmar-plantar erythrodysaesthesia (hand-foot) syndrome.
A pharmacovigilance plan for Inlyta® will be implemented as part of the marketing authorisation.

* On September 04, 2012,  Pfizer has announced that the European Commission (EC) has granted marketing authorization for Inlyta® (axitinib) for the treatment of adult patients with advanced renal cell carcinoma.




Patents:

 

 

 

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization: 2012-01-27

UE authorization: 2012-09-04

Favourable opinion UE: 2012-05-24

Favourable opinion USA:

Orphan status USA:

Orphan status UE: 2011-02-23

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes