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Novartis drug Afinitor(R) recommended by CHMP for European Union approval to treat select GI and lung neuroendocrine tumors

(GLOBE NEWSWIRE via COMTEX) -- Novartis International AG / Novartis drug Afinitor(R) recommended by CHMP for European Union approval to treat select GI and lung neuroendocrine tumors . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

- If approved, Afinitor would be first treatment in EU indicated for advanced progressive, nonfunctional lung NET and first oral therapy for this type of GI NET

- Advanced, progressive, nonfunctional GI and lung neuroendocrine tumors (NET) are rare cancers with limited treatment options and poor outcomes[1,[2]

- CHMP positive opinion based on pivotal study showing everolimus significantly improved PFS and reduced risk of progression vs placebo[3]

Basel, April 29, 2016 - Novartis today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Afinitor(R) (everolimus) tablets for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin in adults with progressive disease. If approved by the European Commission (EC), Afinitor would address an unmet need as there are currently few or no treatment options in Europe for patients with these diseases.

"This important milestone reinforces our long-standing commitment to the NET community by providing solutions to help improve outcomes for patients with these rare and difficult-to-treat cancers," said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs.

Neuroendocrine tumors are a type of cancer that originate in neuroendocrine cells throughout the body, and most commonly arise in the GI tract, lungs or pancreas[1],[4]. NET can be defined as functional or nonfunctional[5]. The majority of patients with NET (72%) have nonfunctional NET, which are characterized by symptoms caused by tumor growth, such as intestinal obstruction, pain and bleeding for GI NET, and asthma, chronic obstructive pulmonary disease and pneumonia for lung NET[5],[6],[7],[8]. In contrast, functional NET are characterized by symptoms caused by the oversecretion of hormones and other substances[5]. Five to 44% (depending on site of tumor origin) of those with GI NET and 28% of those with lung NET have advanced disease at time of diagnosis, meaning the cancer has spread to other areas of the body and patients face limited treatment options[1],[4]. Progression, or the continued growth or spread of the tumor, is typically associated with poor prognoses[9].

The positive CHMP opinion was based on efficacy and safety data from a pivotal Phase III study (RADIANT-4) showing everolimus reduced the risk of progression in patients with progressive, well-differentiated, nonfunctional, locally advanced or metastatic NET of GI or lung origin by 52% (hazard ratio [HR] = 0.48; 95% confidence interval [CI], 0.35-0.67; p<0.00001) vs placebo. Additionally, the data showed everolimus increased median progression-free survival (PFS) by 7.1 months: median PFS by central review was 11.0 months (95% CI, 9.2-13.3) in the everolimus arm and 3.9 months (95% CI, 3.6-7.4) in the placebo arm[3].

In the pivotal trial, the most common treatment-related grade 3/4 adverse events (AEs) (>=5%) for everolimus and placebo, respectively, were stomatitis (9.0% vs 0.0%), diarrhea (7.0% vs 2.0%) and infections (7.0% vs 0.0%)[1]. The most common treatment-related, all-grade AEs (incidence >=10%) were stomatitis (63%), diarrhea (31%), fatigue (31%), infections (29%), rash (27%) and peripheral edema (26%)[3].

The EC typically adheres to the recommendation of the CHMP and delivers its final decision within three months. The decision will be applicable to all 28 European Union member states plus Iceland and Norway.

In February, the US Food and Drug Administration approved Afinitor for the treatment of adult patients with progressive, well-differentiated, nonfunctional NET of GI or lung origin that are unresectable, locally advanced or metastatic. Additional worldwide regulatory filings for this indication are underway.

RADIANT-4 Study Design

RADIANT-4 (RAD001 In Advanced Neuroendocrine Tumors) is a Phase III prospective, double-blind, randomized, parallel group, placebo-controlled, multicenter study. It examined the efficacy and safety of everolimus plus best supportive care (BSC) vs placebo plus BSC in 302 patients with unresectable, progressive, well-differentiated, nonfunctional, locally advanced or metastatic...


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