Roche shares hit 52-week low, and final decision is expected by mid-September.

Roche’s Genentech confirmed that FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 12–1 in favor of retracting Avastin’s existing provisional endorsement as first-line therapy combined with paclitaxel against advanced Her2-negative breast cancer. FDA is expected to make a final decision on whether to rubber stamp the committee’s recommendation by September 17.

Genentech admits that it is “disappointed by the ODAC conclusion” and says that it will continue to discuss data from the three relevant Phase III Avastin studies. “We believe Avastin should be an option for women with this incurable disease,” stresses Sandra Horning, M.D., Genentech’s svp and global head of clinical development hematology/oncology. The firm also points out that whatever the outcome, the U.S. ruling will not impact Avastin’s sanctioned uses for other cancer types or affect any approvals in other countries.

News of the ODAC’s recommendation caused Roche’s shares to slide 4.2% on the previous day’s close, effectively hitting a 52-week low and hovering at about the CHF 135–137 mark as the day’s announcement took its toll.

Avastin’s use in the U.S. as first-line combination therapy for Her2-negative breast cancer was sanctioned in February 2008 under FDA’s accelerated approval program. The decision was based on data from the Phase III E2100 study demonstrating an improvement in progression-free survival (PFS), Genentech explains. In November last year the firm submitted two sBLAs to FDA based on the Phase III Avado and Ribbon 1 trials, as part of its push to convert the accelerated approval to full approval. The two studies evaluated Avastin in combination with either docetaxel chemotherapy or with a taxane, anthracycline-based or capecitabine chemotherapy in women with advanced, previously untreated Her2-negative breast cancer.

Avastin was first approved for the treatment of breast cancer by the EMEA in combination with paclitaxel for first-line therapy of advanced Her2-negative disease in 2007. In July 2009, the approval was expanded to include Avastin in combination with docetaxel.

Avastin is currently approved in major markets including the U.S. and Europe for the treatment of advanced stages of colorectal cancer, breast cancer, non-small-cell lung cancer, and kidney cancer. The drug is also available in the U.S. for the treatment of patients with advanced brain cancer.

As Roche’s top-selling drug in 2009, Avastin made sales of CHF 6.2 billion (some $5.9 billion), up 21% on 2008 in local currencies, and representing 16% of overall sales.

Source: GEN

Popularity: 2% [?]

Teva Pharmaceutical agreed to pay OncoGenex Pharmaceuticals $110 million in the near term in exchange for global rights to the latter’s Phase III cancer therapy OGX-011. Oncogenex will receive up to $370 million if all goals including regulatory and sales milestones are met.

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Under the terms of the global license, collaboration, and share purchase agreements, Teva will provide OncoGenex with a $60 million initial cash payment, which includes a $10 million equity investment in OncoGenex common stock at a price of $37.38 per share. Teva will also pay $20 million up front and $30 million as a prepayment for OncoGenex’ contribution to the development costs of OGX-011.

In addition, OncoGenex will receive tiered royalties on sales of the product. The royalty percentage will range from the mid-teens to the mid-twenties, depending upon the amount of net sales. Teva is responsible for all commercialization and development expenses. OncoGenex retains an option to co-promote OGX-011 in the U.S. and Canada.

OGX-011 is designed to inhibit the production of clusterin, a protein that is associated with cancer-treatment resistance. It is expected to be used as adjunct therapy to enhance the effectiveness of chemotherapy. Teva and OncoGenex will collaborate on a global Phase III program. Studies to evaluate its use along with first-line and second-line chemotherapy in men with metastatic castrate-resistant prostate cancer are expected to begin in 2010. Another Phase III investigation as a first-line treatment of advanced, unresectable non-small-cell lung cancer is intended to begin by early 2011.

OGX-011 has received fast-track designation from the FDA for the treatment of progressive metastatic prostate cancer in combination with docetaxel. Clusterin is a protein that is over-produced in several types of cancer and in response to many cancer treatments including hormone ablation therapy, chemotherapy, and radiation therapy. Preclinical and other data suggest that clusterin promotes cell survival, according to OncoGenex. Increased clusterin production has been linked to faster rates of cancer progression, treatment resistance, and shorter survival duration.

Teva has two additional clinical-stage oncology candidates. Phase III Stem Ex®, being developed under a joint venture with Gamida Cell, comprises cord blood-derived allogeneic stem cells. Gamida Cell’s technology enables preferential expansion of hematopoietic stem and early progenitor cells to be applied as an alternative for bone marrow transplants in patients with hematological malignancies undergoing myeloablative high-dose chemotherapy.

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Teva is also studying Talampanel in a Phase II glioblastoma trial. It is believed that the compound’s ability to block AMPA receptors may act against malignant gliomas, both slowing their growth and reducing their ability to invade brain tissues.

Source: GEN News

Popularity: 4% [?]

In just the latest sign of just how hot new cancer drugs have become, San Francisco-based Medivation garnered a $110 million upfront payment and a milestone package of $655 million from Astellas for global rights to its experimental prostate cancer drug. The therapy, MDV3100, is currently being evaluated in the Phase III AFFIRM clinical trial in men with castration-resistant prostate cancer who were previously treated with docetaxel-based chemotherapy.

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Medivation also gets a co-promotion deal in the U.S. market, a collaborator to help foot development costs and a partner who will provide royalties for sales outside the United States. “Astellas is the second major collaboration we have completed in the past year, and we are confident we have the right partners in place for each of our late-stage programs–Astellas for MDV3100 and Pfizer for Dimebon,”  said David Hung, M.D., president and chief executive officer of Medivation.

MDV3100 triggers cell death in bicalutamide-resistant cancers via three complementary actions: Blocking testosterone binding to the androgen receptor, impeding movement of the androgen receptor to the nucleus of prostate cancer cells (nuclear translocation), and inhibiting binding to DNA.

Source: FierceBiotech

Popularity: 4% [?]

Roche reported Wednesday that the European Commission approved the expanded use of Avastin (bevacizumab) for first-line treatment of patients with advanced breast cancer in combination with sanofi-aventis’ Taxotere (docetaxel).

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Data from the AVADO study, a Phase III trial of the drug combination in 736 patients, showed improvement in progression-free survival with use of the drug in combination with Taxotere, compared with Taxotere alone.

Avastin is approved in the EU for first-line treatment of patients with advanced breast cancer in combination with paclitaxel, and for the treatment of advanced stages of colorectal, kidney, and non-small-cell lung cancers.

Source: FirstWord

Popularity: 7% [?]

Roche reported that the EMEA’s Committee for Medicinal Products for Human Use supported broadening Avastin’s (bevacizumab) label for the first-line treatment of patients with metastatic breast cancer. The recommendation was made to allow the drug’s use in combination with sanofi-aventis’ Taxotere (docetaxel) for these patients.

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Avastin is already approved in Europe, in combination with paclitaxel, as a first-line treatment for patients with metastatic breast cancer. The drugmaker said the positive opinion for the combination of Avastin plus Taxotere was based on Phase III data from the 736-patient AVADO study, which showed that those given Avastin plus sanofi-aventis’ chemotherapy drug experienced increased progression-free survival, compared with Taxotere alone.

Avastin is also cleared for use in Europe to treat advanced stages of colorectal, kidney, and non-small-cell lung cancers.

Source: FirstWord

Popularity: 4% [?]

OncoGenex said Wednesday it reached an agreement with the FDA, through the special protocol assessment process, to amend the design of a Phase III trial of its prostate cancer drug, OGX-011. According to the company, the study population has been amended to evaluate patients receiving first-line chemotherapy, rather than those receiving second-line chemotherapy. Shares in OncoGenex rose as much as 17 percent in reaction to the news.

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In the randomised trial, 800 patients with metastatic castrate-resistant prostate cancer will receive either OGX-011 plus chemotherapy, or only chemotherapy. Scott Cormack, CEO of OncoGenex said that the company is “ready to proceed with two Phase III trial designs from the FDA via the SPA process… The trial for first-line treatment evaluates overall survival benefit for OGX-011 while the trial for second-line treatment evaluates for a durable pain palliation benefit.”

OncoGenex previously disclosed that it was seeking a partner to develop the drug, which has been granted FDA fast-track designation for the treatment of progressive metastatic prostate cancer in combination with sanofi-aventis’ Taxotere (docetaxel). In a note to investors, Rodman & Renshaw analyst Simos Simeonidis indicated OncoGenex will likely now be able to gain an advantage in future partnership discussions around the drug.

Source: FirstWord

Popularity: 5% [?]

Pfizer’s most advanced cancer program suffered a second blow with the company calling off Phase III trials evaluating Sutent as a first-line treatment of patients with advanced breast cancer. The independent Data Monitoring Committee found that the primary endpoint of superior progression-free survival would not be achieved.

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In April, Pfizer stopped a late-stage trial comparing Sutent to standard-of-care in advanced breast cancers citing a similar inability to significantly improve progression-free survival. Even with these first results from a program evaluating a combination therapy not showing an improvement, the firm says that it will continue on its path to evaluate Sutent in various regimens against solid tumors.

Sutent is already approved for gastrointestinal stromal tumors and advanced/metastatic renal cell carcinoma. It is in a slew of mid- to late-stage studies including advanced non-small-cell lung cancer, advanced colorectal cancer, advanced hepatocellular carcinoma, and advanced hormone-refractory prostate cancer.

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The latest trial to be stopped was evaluating Sutent plus paclitaxel versus bevacizumab plus paclitaxel. Ongoing Phase III trial investigations in advanced breast cancer include Sutent plus docetaxel versus docetaxel for first-line treatment and another looking at Sutent plus capecitabine versus capecitabine for second-line treatment. Analysis from both is expected by the end of the year or early next year.

Source: GEN News

Popularity: 4% [?]

New Phase III data for AstraZeneca’s Zactima (vandetanib) presented at ASCO showed that the drug reduced the risk of disease progression by 21 percent in patients with advanced non-small-cell lung cancer when combined with sanofi-aventis’ Taxotere (docetaxel), compared with Taxotere therapy alone. The company indicated that it would file Zactima for FDA approval by the end of the month.

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In the ZODIAC study, 1391 patients who were previously treated with one anti-cancer therapy for advanced NSCLC were randomised to treatment with either Zactima plus Taxotere, or Taxotere alone. Findings showed that median progression free survival (PFS) was 17.3 weeks for the group that received the combination therapy, compared with 14 weeks for the Taxotere-only arm.

AstraZeneca’s medical science director Peter Langmuir stated that “for the first time, we are actually improving efficacy…For patients in second-line treatment, there are three agents approved; none of them has been shown to be any better than docetaxel,” he explained. Lead researcher Roy Herbst added that he believes “this study will have immediate clinical implications,” and he said that more research should be undertaken to determine which patients are most likely to respond to the combination treatment.

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The drugmaker also presented details from two other previously reported studies, one of which involved Roche’s and OSI’s Tarceva (erlotinib), and the other Eli Lilly’s Alimta (pemexetred). Neither study met its primary endpoint in PFS. Langmuir stated that Zactima’s advantage would be as a proven combination therapy.

Source: FirstWord

Popularity: 6% [?]

Researchers said Tuesday that data from a Phase II study showed that Abraxis’ Abraxane (nab-paclitaxel) “nearly doubled” progression-free survival when used as a first-line treatment in women with metastatic breast cancer, compared to those who received sanofi-aventis’ Taxotere (docetaxel). Lead study author William Gradishar stated that the results, published in the Journal of Clinical Oncology, “clearly [suggest] Abraxane is as good as Taxotere in the study and appears to be somewhat more effective and better tolerated.”

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In the study, 302 women with previously untreated metastatic breast cancer were randomised to four treatment arms. Three of the groups received Abraxane at varying doses and intervals, including weekly with the fourth week off, and the fourth group received Taxotere every three weeks. Data demonstrated that a weekly dose of Abraxane kept cancer from progressing for almost seven months longer than Taxotere, researchers noted.

In further comments on the study, Gradishar indicated that the data “[reaffirm] that Abraxane is a very active drug, is well-tolerated and appears to have a greater anti-tumour effect than what you would see with what had been presumed to be the most active drug.” A late-stage trial comparing the same drug regimens is being planned.

Source: FirstWord

Popularity: 4% [?]

According to a letter posted on the FDA’s website on Wednesday, the US regulator cited sanofi-aventis for distributing promotional material containing claims that “overstate the efficacy” of Taxotere (docetaxel).

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In its letter dated April 16, the FDA referred to the reprint of a journal article that the agency said it obtained at a medical conference last June. The FDA indicated that the article was “false or misleading” because it made unsubstantiated claims about the benefits of Taxotere compared to paclitaxel. “These claims misleadingly suggest that Taxotere is superior to paclitaxel in the treatment of patients with locally advanced or metastatic breast cancer after failure of prior chemotherapy,” the regulator wrote, adding that it “is unaware of substantial evidence to support these claims.”

The FDA asked sanofi-aventis to stop distributing the item, and other materials that might be in violation of regulations, and to respond by April 30 to state whether the company intended to comply with the request. In addition, the agency asked the drugmaker to supply a list of other materials that violated FDA guidelines and to explain how use of these materials would be discontinued.

Source: FirstWord

Popularity: 4% [?]