1stOncology™: Cancer Intelligence Service – Page 18298 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Market Access Granted in France for Aggressive non-Hodgkin Lymphoma Treatment, PIXUVRI® (pixantrone)

On August 19, 2013 Cell Therapeutics reported that the Transparency Commission (Commission de la Transparence or CT) of the French National Health Authority (Haute Autorite de Sante or HAS) has granted market access for the medicinal product PIXUVRI (pixantrone) as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (patients with aggressive B-cell NHL who failed 2 or 3 prior lines of therapy) (Press release , AUG 18, 2013, View Source;p=RssLanding&cat=news&id=1848275 [SID:1234500566]). The next and final step in France’s pharmaceutical reimbursement process is inclusion on the list of medicines approved for hospital use and subsequent publication in the Journal Officiel in France, which CTI now intends to pursue.
The CT noted that aggressive NHL is a serious disease and that there are no standard treatments for patients with this stage of disease. All registered pharmaceuticals in France are subjected to an evaluation process known as Evaluation of Therapeutic Benefit (Amelioration du Service Medical Rendu, or ASMR) by the CT, with the resulting evaluation expressed as a classification between 1 and 6. The CT rated PIXUVRI at level 5, which allows PIXUVRI to be included in the reimbursed drugs list for hospital use. The CT will reassess the ASMR rating for PIXUVRI within two years.

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!

(Company Web Page, AllaChem, AUG 16, 2013, View Source [SID:1234502046])

(Filing, 10-Q, Prothena, AUG 13, 2013, View Source [SID:1234505969])

Vical Phase 3 Trial of Allovectin Fails to Meet Efficacy Endpoints

On August 12, 2013 Vical reported top-line results from a Phase 3 trial of Allovectin (velimogene aliplasmid), an investigational intratumoral cancer immunotherapy, in patients with metastatic melanoma (Press release Vical, AUG 12, 2013, View Source [SID:1234501043]). The 390-subject trial failed to demonstrate a statistically significant improvement vs. first-line chemotherapy for either the primary endpoint of objective response rate at 24 weeks or more after randomization or the secondary endpoint of overall survival. Trial data will be further analyzed and detailed results will be submitted for publication.

"We are disappointed that the trial did not meet either the primary or secondary efficacy endpoints, even though we believe it was well-designed and well-executed," said Vijay B. Samant, President and Chief Executive Officer of Vical. "Based on this outcome, we are terminating the Allovectin program and focusing our resources on our infectious disease vaccine programs." Mr. Samant added, "We would like to recognize all of the patients and their families, trial investigators and employees who participated in the conduct of this trial and thank them for their efforts."

Teva Receives European Marketing Authorization for Lonquex (XM22 lipegfilgrastim)

On August 8, 2013 Teva reported that the European Commission has granted marketing authorization for Lonquex (lipegfilgrastim) (Press release Teva, AUG 8, 2013, View Source;p=irol-newsArticle&ID=1846232 [SID:1234500815]). This approval provides the regulatory framework for the commercialization of Lonquex in all twenty eight countries of the European Union plus Norway, Iceland and Liechtenstein.

Lonquex is a long-acting recombinant granulocyte colony-stimulating factor (G-CSF) with the active ingredient lipegfilgrastim – a novel glycoPEGylated (PEG; polyethylene glycol) filgrastim molecule. Lonquex (lipegfilgrastim) is indicated for the reduction of the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes). Lonquex is intended as a once-per-cycle fixed dose, subcutaneous injection for neutrophil support in cancer patients receiving myelosuppresive chemotherapy (with the exception of chronic myeloid leukemia and myelodysplastic syndromes).

"This is an important milestone for Teva Specialty Medicines in Europe and demonstrates our commitment to making a difference to the lives of those with cancer" said Dr. Rob Koremans, President and CEO of Teva Specialty Medicines. "Lonquex is an alternative G-CSF treatment for helping manage neutropenia during myelosuppressive chemotherapy. The European approval comes earlier than expected, just 8 weeks after the positive CHMP opinion. We look forward to providing this oncology supportive care treatment option in all European Union member states."

Lonquex has undergone a full clinical development program, including pre-clinical to clinical in vivo studies, as part of the efficacy and tolerability assessment for use with chemotherapy patients.

Dr. Michael Hayden, Teva’s President of Global R&D and Chief Scientific Officer, commented: "Effective prevention and treatment of febrile neutropenia is an important consideration for clinicians managing cancer patients who are undergoing cytotoxic chemotherapy. As well as targeting cancer cells, chemotherapy affects rapidly-dividing bone marrow cells, thereby dramatically reducing a patient’s ability to fight off infection, with potentially serious consequences. This approval is testament to Teva’s commitment to bringing new and alternative treatments to market to support clinicians in caring for patients."