Blood Cancer : Market for Celgene blood cancer drug seen growing after trial

Celgene Corp said a late-stage trial of its cancer drug Revlimid met the main goal of improving survival in newly diagnosed blood cancer patients, potentially opening up the path for a wider use of the drug.

The company's shares were up 7 percent at $133.07 in morning trade. Analysts said the data was largely expected and will also pave the way for a European approval application for the drug.
Celgene had withdrawn the European marketing application for a wider use of the drug in June 2012, after regulators asked for more data.

"We note that this news removes a key overhang for Celgene as with these data, they can now file for approval in the EU ... (The) EU filing may come by end of the year," Deutsche Bank Analyst Robyn Karnauskas wrote in a note.

Celgene said it will start discussions with regulators and plans to submit applications in the United States, Europe and other markets.

Regulatory decision from United States and European agencies are expected in 2015, analysts said.

Revlimid is Celgene's flagship blood cancer drug and is already approved for use in multiple myeloma patients who have failed at least one prior therapy, mantle cell lymphoma and transfusion-dependent anemia caused by myelodysplastic syndromes - a blood disorder.

The late-stage study tested the oral drug in patients with newly diagnosed multiple myeloma, and showed a statistically significant improvement in survival without the cancer worsening.

The evaluation of safety and efficacy was ongoing and the results will be presented at an upcoming medical meeting, Celgene said.

Deutsche Bank's Karnauskas said that while the magnitude of benefit with continuous Revlimid usage was not disclosed, she expected progression-free survival in the group to be 35-36 months.

"Notably, we expect control arm to do 25-26 months in this study," she said.

Multiple myeloma is the second most commonly diagnosed blood cancer. It starts in the plasma cells in the bone marrow and ultimately disrupts the production of normal blood cells.

The American Cancer Society estimates there will be about 22,350 new cases diagnosed in 2013 and about 10,710 deaths.

Revlimid, Celgene's most important growth driver, brought in sales of about $1 billion during the first quarter.

The approval for mantle cell lymphoma came in early last month.

According Thomson Reuters Pharma, Revlimid annual sales are expected to reach $4.2 billion in 2013 and $5.37 billion in 2015.

Source : courant.com

Blood Cancer : Thalidomide and turmeric team up to kill blood cancer cells

Scientists in the United States have combined banned morning sickness drug thalidomide with a pigment from curry spice turmeric to create a new drug compound that kills cancer cells.

In research published in Organic & Biomolecular Chemistry, the spice-drug hybrid is shown to cause cell death in multiple myeloma, the second most common type of blood cancer.

Thalidomide was introduced in the 1950s to treat morning sickness in pregnant women, but was then banned because of its link to birth defects. The drug has recently been 'rediscovered' and approved for the effective treatment of multiple myeloma. It works by disturbing the microenvironment of tumour cells in bone marrow and modulating the immune system, but it breaks down in the body, causing side effects such as thrombosis.

Turmeric is a spice commonly used in South Asian and Middle Eastern cooking. Curcumin, a pigment in turmeric that gives it its characteristic yellow colour, has also been shown to have activity against cancer, including myeloma, but it has limited solubility in water so it isn't easily taken up by the body.

The scientists have taken these two components and created a hybrid scaffold that combines structural features of the two. Analogues of this scaffold that have shown enhanced solubility and higher toxicity to myeloma cells than either thalidomide or curcumin, or a mixture of the two.

Source : bionity.com

Blood Cancer : Roche’s blood cancer drug receives FDA Priority Review

Swiss pharma company Roche has announced that its chronic lymphocytic leukemia drug has been granted Priority Review by the US Food and Drug Administration (FDA).

Chronic lymphocytic leukemia (CLL) is one of the most common forms of blood cancer. In May 2013, obinutuzumab received Breakthrough Therapy Designation from the FDA, which is designed to speed up the development and review of medicines that treat life-threatening diseases.

Roche's Biologics License Application (BLA) was accepted based on final phase 3 clinical trial data, which found that obinutuzumab demonstrated a statistically significant 86% reduction in the risk of disease worsening or death when combined with chlorambucil compared to chlorambucil alone in previously untreated people with CLL and co-existing medical conditions.

"We're excited that the FDA has granted GA101 in CLL both Breakthrough Therapy Designation and Priority Review. These FDA designations acknowledge the promising trial results with GA101 and will hopefully allow this novel medicine to reach the people who need it in an expedited time frame."

Hal Barron, M.D., chief medical officer and head, Global Product Development.

The FDA confirmed that the Priority Review date for obinutuzumab is December 20th 2013.

The drug is currently also being investigated in clinical trials as a treatment for other diseases, including indolent non-Hodgkin's lymphoma (NHL) and diffuse large B-cell lymphoma (DLBCL).

Yesterday, Roche subsidiary Genentech received FDA Priority Review status for a Perjeta (pertuzumab) regimen to be used before surgery (neoadjuvant treatment) in people with HER2-positive early stage breast cancer.

Source : pharmaphorum.com