Strong prospects for Novartis cancer drug, say analysts
pharmafile | April 24, 2009 | News story | Research and Development, Sales and Marketing |Â Â Afinitor, NovartisÂ
The FDA has approved Novartis's Afinitor for advanced renal cell carcinoma patients who have progressed after first-line Sutent or Nexavar treatment. Not only is this Afinitor's first approval in the oncology market, the commercial potential in this indication is considerable as there are currently no approved second-line therapy options, say analysts Datamonitor.
Novartis' Afinitor (everolimus) has received FDA approval for the second-line treatment of advanced renal cell carcinoma (RCC) following treatment failure with Pfizer's Sutent (sunitinib) and/or Bayer/Onyx Pharmaceuticals' Nexavar (sorafenib).
The approval was based on the results of a placebo-controlled phase III trial, RECORD-1 (renal cell cancer treatment with oral RAD001 given daily). In this trial, 410 advanced RCC patients were randomized to receive Afinitor or placebo in combination with best supportive care.
The results showed that progression-free survival, the primary endpoint, was significantly improved in patients treated with Afinitor, with an increase to four months compared with 1.9 months. The probability of being progression-free was also reported at 26% for patients treated with Afinitor compared with 2% for patients in the control group after six months of treatment.
Afinitor is an oral mTOR (mammalian target of rapamycin) inhibitor that blocks cellular metabolism, growth, proliferation and angiogenesis. Novartis has also filed for EU and Japanese approval of Afinitor in advanced RCC. In addition, the drug is currently undergoing phase III trials for breast cancer, gastrointestinal stromal tumors, neuroendocrine tumors and diffuse large B-cell lymphoma. The drug, under the trade name Certican, is approved in the EU for the management of organ transplant rejection.
Datamonitor forecasts the incidence of RCC to reach over 93,000 in 2009, and the disease is believed to account for 85% of all kidney cancers. Sutent and Nexavar are the current standard first-line treatment options for advanced RCC patients, who represent 25% of the total RCC patient population. However, there is currently no effective treatment option available for patients who become refractory to these drugs.
Afinitor is the fifth targeted therapy to enter the RCC market following the approvals of Nexavar, Sutent, Torisel (temsirolimus; Wyeth) and Avastin (Genentech/Roche/Chugai). Afinitor is the fourth targeted therapy to enter the RCC market following the approvals of Nexavar, Sutent and Torisel (temsirolimus; Wyeth).
However, Novartis's strategy of targeting a selected subset of the RCC market will be beneficial to the drug's uptake. Intended for use in a selected underserved patient group, Afinitor is likely to become a popular second-line therapy in the RCC market. Furthermore, its commercial potential may expand in the future: the number of patients who are treated with Sutent or Nexavar in the first-line then eventually become refractory is increasing.
Related research:
Stakeholder Insight: Renal Cancer – Targeted therapies rapidly take hold of market priced $15,200, DMHC2288
Novartis AG: PharmaVitae Profile priced $5,700, CSHC1411
Pipeline Insight: Molecular Targeted Cancer Therapies – More pipeline activity, less product differentiation priced $15,200, DMHC2452
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