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EU approves Roche's Avastin for platinum-resistant recurrent ovarian cancer

On August 6, 2014 Roche reported that the European Commission (EU) approved the use of Avastin (bevacizumab) in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin chemotherapy as a treatment for women with recurrent ovarian cancer that is resistant to platinum-containing chemotherapy (Press release Hoffmann-La Roche, AUG 6, 2014, View Source [SID:1234500970]).

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The EU approval was based on results of the phase III AURELIA study which involved women with recurrent, platinum-resistant ovarian cancer who received either chemotherapy or Avastin in combination with chemotherapy.1 Results showed that the addition of Avastin to chemotherapy gave a clinically meaningful benefit, nearly doubling the median progression free survival (PFS) from 3.4 months to 6.7 months (HR=0.38, p<0.0001).1,2

"European approval of Avastin for recurrent, platinum-resistant ovarian cancer is good news because Avastin can help women live longer without their cancer progressing, which is an important treatment goal in advanced disease," said Sandra Horning, M.D., Roche’s Chief Medical Officer and Head, Global Product Development. "Avastin is the first biologic medicine approved by the EU for women with this difficult to treat disease."

Ovarian cancer has the highest mortality rate of all gynaecological cancers.3 Of the 44,000 women diagnosed each year in the European Union many will have advanced disease that will return after initial treatment.4-6 When treating recurrent ovarian cancer, the time between receiving the last dose of platinum-based chemotherapy and disease recurrence is used to help determine the choice of chemotherapy used in the next line of treatment. Patients are said to have ‘platinum-resistant’ disease if their disease worsens between one and six months following completion of their platinum-based chemotherapy, and ‘platinum-sensitive’ disease if it worsens more than six months after. A quarter of those who relapse after initial treatment, over 10,000 women a year in the European Union, will have platinum-resistant cancer, the most difficult to treat form of the disease.

This approval will enable the use of Avastin in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin for the treatment of women with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with Avastin or other VEGF inhibitors or VEGF receptor–targeted agents.

AURELIA is the fourth phase III study of Avastin in ovarian cancer to show that adding Avastin to chemotherapy significantly increased the time women with ovarian cancer lived without their disease worsening.1,7-9 In 2011, Avastin was approved in the EU as a front-line treatment for advanced ovarian cancer based on the pivotal GOG 0128 and ICON7 phase III studies. In 2012, Avastin was approved in the EU as a treatment for recurrent, platinum-sensitive ovarian cancer based on the results of the pivotal phase III OCEANS study.

FDA Grants Fast Track Designation to CTI BioPharma’s Pacritinib, a Novel JAK2 Inhibitor for the Treatment of Myelofibrosis

On August 7, 2014 CTI BioPharma reported that pacritinib has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of intermediate and high risk myelofibrosis, including but not limited to patients with disease related thrombocytopenia, patients experiencing treatment emergent thrombocytopenia on other JAK2 therapy or patients who are intolerant to or whose symptoms are sub-optimally managed on other JAK2 therapy (Press release CTI BioPharma, AUG 6, 2014, View Source [SID:1234500689]). Pacritinib is an oral tyrosine kinase inhibitor with dual activity against JAK2 and FLT3. The drug candidate is currently being evaluated in two Phase 3 clinical trials, known as the PERSIST program, for patients with myelofibrosis.

“We are very pleased that the pacritinib development program in myelofibrosis has been granted Fast Track designation, and we look forward to continuing to work closely with the FDA on this important drug candidate,” stated James A. Bianco, M.D., President and CEO. “We believe that pacritinib’s unique profile has the potential to serve an unmet medical need that currently exists in this patient population, particularly for those patients with disease or therapy-related low platelet counts.”

ARIAD Announces Commercial Agreement for Iclusig (Ponatinib) in Israel

On August 5, 2014 ARIAD and Medison Pharma Ltd, Israel’s leading international marketing group for innovative pharmaceuticals, reported that ARIAD has granted Medison exclusive rights to commercialize Iclusig (ponatinib) in Israel in patients with Philadelphia-positive (Ph+) leukemias (Press release, Ariad, AUG 5, 2014, View Source;p=irol-newsArticle&ID=1955243 [SID:1234508551]).

Under the terms of the agreement, ARIAD Pharmaceuticals (Israel) Ltd will be the Marketing Authorization Holder (MAH) of Iclusig in Israel, and Medison will be responsible for sales and marketing, medical affairs, regulatory support, as well as obtaining, in collaboration with ARIAD, the pricing and reimbursement approval of Iclusig.

"The agreement with Medison illustrates our ongoing commitment to provide patients access to Iclusig in geographies outside of our core commercial footprint," said Marty J. Duvall, executive vice president and chief commercial officer of ARIAD. "Medison is uniquely qualified to provide the complete spectrum of integrated services for Iclusig in Israel, including a proven track record with oncology and hematology products."

ARIAD has submitted its Marketing Authorization Application for Iclusig in Israel, which is currently under review with the Israel Ministry of Health. Marketing approval and commercial launch of Iclusig are expected to occur in the second half of 2015.

"We are very pleased with our new partnership with ARIAD. It is another step in fulfilling Medison’s continuing vision to provide innovative and unique treatments to patients in Israel," said Meir Jakobsohn, Chief Executive Officer and Founder of Medison Pharma. "One of Medison’s main focuses is providing treatments in the field of hematology. ARIAD’s treatment offers new hope for refractory CML patients."

According to the EMA’s orphan drug designation and the HAEMACARE project, there are approximately 700 patients in Israel with CML.

"Iclusig is a very effective treatment option with utmost importance to CML or Ph+ALL patients who are resistant to dasatinib or nilotinib and for those patients with the T315I BCR-ABL mutation," said Prof. Arnon Nagler, director of hematology at Sheba Medical Center. "It is of vital importance that Iclusig be available to the Israeli market."

Population pharmacokinetics of rilotumumab, a fully human monoclonal antibody against hepatocyte growth factor, in cancer patients.

It exhibited linear and time-invariant kinetics over a dose range of 0.5-20 mg/kg. Typical systemic clearance and central volume of distribution were 0.184 L/day and 3.56 L, respectively (J Pharm Sci. 2014 Jan;103(1):328-36. doi: 10.1002/jps.23763. Epub 2013 Nov 1. View Source). Body weight is the most significant covariate, and sex, cancer type, coadministration of chemotherapeutics, baseline plasma HGF and tumor MET levels, and renal and hepatic functions did not have an effect on rilotumumab pharmacokinetics. The concentration-time profiles for the rilotumumab clinical regimens were projected well with the model.

FDA Accepts Supplemental New Drug Application for Jakafi® (ruxolitinib) and Priority Review Granted

On August 5, 2014 Incyte reported that the U.S. Food and Drug Administration (FDA) has accepted for filing the supplemental New Drug Application (sNDA) for ruxolitinib as a potential treatment of patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea (Press release Incyte, AUG 5, 2014, View Source [SID:1234500688]). The sNDA includes results from the RESPONSE Phase III trial, which were recently presented at the 2014 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting. RESPONSE was conducted under a Special Protocol Assessment (SPA) from the FDA.

The Prescription Drug User Fee Act (PDUFA) date for the sNDA for ruxolitinib is set for December 5, 2014.

“We are pleased to have received the acceptance of our sNDA filing by the FDA, and we believe that the submission contains a robust data set,” stated Richard Levy, M.D., Executive Vice President and Chief Drug Development and Medical Officer of Incyte. “We look forward to working with the FDA to complete its review of this application”.

PV is a form of blood cancer leading to the overproduction of normal red blood cells, white blood cells and platelets. Patients with uncontrolled PV have an increased risk of cardiovascular complications such as stroke, pulmonary embolism, deep vein thrombosis and heart attack.