On October 24, 2014 Astellas Pharma Europe reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending a variation to amend the Marketing Authorisation for enzalutamide (trade name XTANDI) (Press release Astellas, OCT 26, 2014, View Source [SID:1234500880]). The positive opinion relates to the use of enzalutamide for the treatment of adult men with metastatic castrate-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen-deprivation therapy in whom chemotherapy is not yet clinically indicated.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"For us urologists treating patients with mCRPC, this positive opinion from the CHMP is an important milestone towards making enzalutamide available across Europe. Enzalutamide marks a significant step for many patients who live with mCRPC as encouraging, it demonstrates benefits in overall survival, has a positive impact on quality of life and has been shown to be well tolerated", said Professor Bertrand Tombal, MD, PhD, Chairman of the Division of the Urology and Professor of Physiology, Université Catholique de Louvain (UCL) and European Principal Investigator for PREVAIL. "As well as clear efficacy and safety benefits over placebo, enzalutamide has the additional advantage of not requiring steroids to be taken concomitantly and requires only basic monitoring, making it a simple option for both healthcare professionals and patients. It is my hope that the European Commission follows this opinion, providing us with a viable new treatment option for those patients not suitable for chemotherapy.

The positive CHMP opinion is based on results from the phase III PREVAIL study which showed that men treated with enzalutamide demonstrated a statistically significant reduction both in the risk of death and a delay in cancer progression and the time to initiation of chemotherapy as compared to those treated with placebo.

Enzalutamide reduced the risk of death by 29% (HR=0.71; p<0.001), compared with placebo. In addition, treatment with enzalutamide significantly reduced the risk of radiographic progression or death by 81% compared with placebo treatment (HR=0.19; p<0.001). Men taking enzalutamide experienced a 17-month delay in the time to initiation of chemotherapy compared with men taking placebo (28.0 months versus 10.8 months; HR=0.35; p<0.0001).

The most common clinically relevant adverse events among the enzalutamide population as compared with placebo-treated patients in the PREVAIL trial included fatigue, hot flush and hypertension. Hypertension was observed in 13% of enzalutamide versus 4% of placebo-treated patients. Grade 3 or higher cardiac adverse events were reported in 3% of enzalutamide versus 2% of placebo-treated patients. One patient (0.1%) out of the 871 patients treated with enzalutamide, and one patient (0.1%) receiving placebo experienced a seizure.

In the EU, the European Commission generally follows the recommendations of the CHMP opinion and delivers its final decision around two months after the CHMP recommendation.

XTANDI is currently licensed in Europe for the treatment of adult men with mCRPC whose disease has progressed on or after docetaxel therapy. Marketing authorisation was granted by the European Commission in June 2013.

On October 25th 2014 Betta Pharmaceuticals and Xcovery reported that Xcovery will get an equity investment worth 20 million dollars from Betta Pharmaceuticals (Press release, Betta Pharmaceuticals, OCT 25, 2014, View Source;id=1492 [SID1234516487]). As the leading enterprise in new drug research and development of China, Betta continues to exert efforts in research and development of new drugs after successfully completed the development and marketing of Icotinib Hydrochloride. Located in Florida,U.S.A., Xcovery is a R&D enterprise focusing on development of new generation anti-tumor targeted drugs. Its key program, X-396, is a new generation ALK inhibitor directed at lung cancer, which is now under Phase 1/2 clinical research in the United States. Apart from equity investment, Betta will also get the development right of the X-396 program in China.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

(Press release, Novogen, OCT 24, 2014, View Source [SID:1234506153])

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On October 24, 2014 ARIAD Pharmaceuticals reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted its final opinion on Iclusig (ponatinib) following the recommendations made by the Pharmacovigilance Risk Assessment Committee (PRAC) earlier this month (Press release Ariad, OCT 24, 2014, View Source;p=RssLanding&cat=news&id=1981265 [SID:1234500874]). The PRAC conducted an 11-month review of the available data on Iclusig and consulted with a scientific advisory group in oncology. This week, the EMA recommended that Iclusig continue to be used in accordance with its already approved indications as a treatment of certain leukemias and confirmed that the benefit-risk profile of Iclusig continues to be positive in each of these indications. The EMA also recommended additional warnings in the European product information to minimize the risk of vascular events.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are now well positioned to complete pricing and reimbursement negotiations in Europe and to ensure that Iclusig is available to appropriate Philadelphia-chromosome positive leukaemia patients," said Jonathan E. Dickinson, general manager, ARIAD Pharmaceuticals (Europe). "The authorized indications and the favorable benefit-risk balance of Iclusig give healthcare providers the ability to optimize the use of Iclusig in patients with resistant or intolerant CML."

The authorized indications of Iclusig in Europe, as approved in July 2013, are as follows:

The treatment of adult patients with chronic phase, accelerated phase or blast phase chronic myeloid leukaemia (CML) who are resistant to dasatinib or nilotinib; who are intolerant to dasatinib or nilotinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation, or
The treatment of adult patients with Philadelphia-chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) who are resistant to dasatinib; who are intolerant to dasatinib and for whom subsequent treatment with imatinib is not clinically appropriate; or who have the T315I mutation.

"Over the past year, we have closely monitored patients on Iclusig and are confident that the updated safety information will help us provide this important therapy to patients who have become resistant or intolerant to certain other tyrosine-kinase inhibitors," said Giuseppe Saglio, M.D., professor of internal medicine and haematology at the University of Turin and director of the Department of Internal Medicine and head of the Division of Haematology at the San Luigi University Hospital of the University of Turin in Italy. "The flexibility to reduce the dose after achievement of response is an important factor for physicians in treating CML patients with Iclusig."

The CHMP is a scientific committee composed of representatives from the 28-member states of the EU, and Iceland and Norway. The CHMP reviews medical product applications on their scientific and clinical merit and provides advice to the European Commission, which has the authority to approve medicines for the EU. The European Commission is expected to issue a final legally binding decision on Iclusig in December 2014, which will be valid throughout the EU.