GlaxoSmithKline’s bargaining on Tyverb has failed. The U.K.’s cost-effectiveness watchdog nixed the breast-cancer pill once again–despite the company’s offer to pay for the first three months of treatment.

The National Institute for Health and Clinical Excellence said the drug wasn’t a good value when compared with treatment alternatives. “[E]vidence suggest that it extends life by a small amount of time–around 10 weeks or 2.4 months–and costs thousands of pounds more than one of the more commonly used NHS treatments for this indication,” NICE chief Andrew Dillon said in a statement (as quoted by Dow Jones).

NICE has been fairly skeptical of pricey cancer treatments, and, in spite of new “end-of-life” calculations for drugs for terminal illnesses, remains difficult–but not impossible–to convince. In recent weeks it has rejected one kidney cancer treatment–Bayer’s Nexavar –while accepting AstraZeneca’s lung cancer pill Iressa.

Source: FiercePharma

Popularity: 3% [?]

Agreement is valued at $209 million and includes development of a companion diagnostic.

Clovis Oncology and Avila Therapeutics entered an agreement for the development and commercialization of Avila’s EGFR mutant-selective inhibitor (EMSI) program, currently in preclinical development for the treatment of non-small-cell lung cancer (NSCLC).

In addition to research support, Avila will receive an up-front fee and be eligible to receive development, regulatory, and sales-based milestone payments, with a total potential value of $209 million. Avila will also receive tiered royalties on product sales and will share in selected sublicense income.

The EMSI program targets the T790M mutant form of the EGFR associated with clinical resistance to Tarceva® and Iressa®, Avila explains. It also reportedly targets the initial activating EGFR mutations including L858R and exon 19 deletions while sparing the wild-type EGFR. Because the program targets both the sensitive activating mutations as well as the primary resistance mechanism, it has the potential to treat both first- and second-line NSCLC patients with EGFR mutations, the companies note.

“The T790M mutation seems to be the predominant mechanism underlying the development of resistance of EGFR-mutant lung cancers to specific EGFR kinase inhibitors, and it may well explain why the dramatic responses seen in these cases are of relatively short duration,” says Daniel Haber, M.D., Ph.D., director of the Massachusetts General Hospital Cancer Center, who led the team that initially discovered EGFR mutations in lung cancer.

“The development of a drug that is both mutant-specific and capable of irreversibly binding the enzyme is one of the most exciting new developments in this field. Such an inhibitor could overcome this resistance mutation at dosage levels that would spare the wild-type EGFR in normal tissues.”

Avila and Clovis Oncology will collaborate on preclinical development. Clovis Oncology will be fully responsible for all aspects of development and commercialization, including development of companion diagnostics to prospectively identify patients with clinically arising resistance mutations of the EGFR.

Clovis Oncology has one other molecule in clinical development. CO-101 is in Phase II trials for the treatment of pancreatic cancer. The company is also collaborating with Ventana Medical Systems to develop a companion diagnostic to identify patients with low tumor expression of hENT1, who are expected to benefit from CO-101.

Source: GEN

Popularity: 3% [?]

The more scientists look, the more complex cancer seems to become.

British scientists said on Wednesday they had found a batch of new gene mutations linked to kidney cancer, suggesting even this apparently “straightforward” cancer type can be divided into subtypes requiring tailored treatment.

Clear cell renal cell carcinoma (ccRCC), the most common type of kidney cancer, stands out from other cancers because it is remarkably consistent and the majority of cases are known to be driven by mutations in a single gene, called VHL.

[ad]

Yet when researchers conducted a large DNA sequencing study of more than 3,500 genes from around 100 tumor samples, they found evidence that additional mutations in other genes were also driving cells to become cancerous.

Three of the genes were involved in modifying proteins called histones, which help package DNA into chromosomes and are critical to the functioning of cells, they reported in the journal Nature.

“Even in this clearest of cases, we see evidence for substantial genetic heterogeneity,” said Andy Futreal, co-leader of the Cancer Genome Project at the Wellcome Trust Sanger Institute in Cambridge.

While none of the new mutations accounted for more than 5 percent of cancer cases, the discovery should ultimately help in diagnosis and better selection of treatments for patients.

The latest findings underline the case for personalized medicine, or tailoring drugs to the genetic make-up of individual patients.

Scientists at the Sanger Institute last month also produced genetic “maps” identifying thousands of genetic mutations behind melanoma skin cancer and lung cancer.

Several personalized drugs are already used in cancer, including Roche’s Herceptin for breast cancer and AstraZeneca’s Iressa for lung cancer.

For drugmakers, tailored medicine is both an opportunity and a challenge as sub-dividing tumors by their molecular type shrinks the market for individual therapies.

Kidney cancer kills more than 100,000 people worldwide each year. Recent new drugs against the disease include Pfizer’s Sutent and Bayer’s Nexavar, which block cell proliferation and starve tumors of blood supply.

Source: Reuters

Popularity: 5% [?]

AstraZeneca announced Wednesday that the European Commission approved its oral drug Iressa (gefitinib) for the treatment of adults with locally advanced or metastatic non-small-cell lung cancer with activating mutations of EGFR-TK, across all lines of therapy.

[ad]

The company’s executive vice-president for development, Anders Ekblom, remarked that the approval will give patients with EGFR mutation positive tumours “a more effective and better tolerated alternative to chemotherapy as a first-line treatment.” AstraZeneca also noted that it will conduct a follow-up study to generate more data on the drug’s effectiveness in a Caucasian population, and added that it was in discussions with the EMEA to finalise the study design. Iressa is currently sold in the Asia-Pacific region for patients with NSCLC who have received prior therapy.

Source: FirstWord

Popularity: 4% [?]

Roche announced that the company will commence a late-stage trial investigating whether Tarceva (erlotinib) is superior to chemotherapy as a first-line treatment in patients with non-small-cell lung cancer (NSCLC) who have genetic mutations in their epidermal growth factor receptor (EGFR).

[ad]

News of the upcoming study comes after AstraZeneca said an EU committee adopted a positive opinion for Iressa (gefitinib) in adults with NSCLC with the same gene mutation. Commenting on the potential competition between the products, analyst Michael Leuchten of Deutsche Bank suggested that “we don’t doubt that Iressa will find its place in the treatment of non-small-cell lung cancer, but see little risk to the Tarceva franchise,” adding that “the two treatments are remarkably similar and entering a carved-up market without knock-out data is challenging.”

Deutsche Bank analysts said Iressa, which garnered sales of $250 million in 2008, will likely be a niche product, potentially generating $474 million in revenue in 2014.

Source: FirstWord

Popularity: 4% [?]

AstraZeneca announced Thursday that a committee of the European Medicines Agency recommended approval for Iressa (gefitinib) in adults with locally advanced or metastatic non-small-cell lung cancer (NSCLC) with activating mutations of EGFR-TK.

[ad]

The positive opinion stipulates, however, that the drugmaker must conduct a study to generate further data in a Caucasian population of patients with NSCLC. The drugmaker said it is in talks with the Committee for Medicinal Products for Human Use to finalise the design and endpoints of the trial.

Popularity: 4% [?]

Phase III study findings published in the current issue of The Lancet show that AstraZeneca’s Iressa (gefitinib) demonstrated non-inferior survival compared with sanofi-aventis’ Taxotere (docetaxel) in patients with pre-treated advanced non-small-cell lung cancer (NSCLC). Lead author Edward Kim commented that “the study is the first time in lung cancer that an oral biological agent has been tested head-to-head against chemotherapy.”

[ad]

In the INTEREST study, 1466 patients were randomly assigned either Iressa, given orally once-daily, or Taxotere, administered intravenously every three weeks. Results showed that patients who took Iressa experienced median survival of about 7.6 months, versus 8 months in the Taxotere group. Moreover, after one year, 32 percent of Iressa patients were still alive, compared with 34 percent of those in the comparison group.

In an accompanying commentary, Michael Cullen, of University Hospital Birmingham, noted that Iressa has decreased toxicity compared with chemotherapy and is also available in a convenient formulation. “I think there will be patients for whom it will be favoured,” he noted.

Source: FirstWord

Popularity: 3% [?]