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Celgene Corporation, the manufacturer of Revlimid (lenalidomide), announced on Monday that the company plans to file for approval of Revlimid as a treatment for newly diagnosed multiple myeloma. Celgene intends to file for regulatory approval in the United States and Europe in the second half of this year.

“Our objective is to make sure that the patients who have a fatal disease, a currently incurable disease, can take medicines that turn this into a chronic treatable disease,” said Celgene’s President and CEO Sol Barer during the announcement. “That is the mission …

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Innate Pharma And Celgene To Collaborate On Trial Combining Revlimid With IPH 2101 Therapies – Innate Pharma and Celgene will collaborate to evaluate the clinical potential of Celgene’s Revlimid (lenalidomide) plus Innate Pharma’s IPH 2101 in myeloma patients who have failed first-line therapy. In vitro studies on myeloma cell lines have shown that the two drugs may have a synergistic effect. Innate Pharma hopes to submit a request with the Food and Drug Administration in early 2010 to receive authorization to administer the drugs in humans. For more information, please see the Innate Pharma press release.  

Myeloma UK Launches The Innovative Myeloma Clinical Trial Network – The Clinical Trial Network will design and manage a portfolio of early phase trials of myeloma drugs by drawing on a collaboration of clinical specialists, researchers, pharmaceutical companies, and the National Health Service’s regulatory bodies. Eight research centers around the UK will be involved in the trials included in the portfolio. Myeloma patients will be able to take part in the trials at these centers. The first trials are expected to begin recruiting patients in early 2010. For more information, please visit the Myeloma UK Web site.

Peter Boyle Memorial Raises $700,000 For The IMF – The Third Annual Peter Boyle Memorial raised $700,000 for the International Myeloma Foundation. The event was launched three years ago by Boyle’s widow to help fund the battle against multiple myeloma. For more information, please visit the Los Angeles Times Web site.

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FDA Grants Priority Review Status To Velcade – The U.S. Food and Drug Administration (FDA) granted priority review to the supplemental new drug application for Velcade (bortezomib) from Millennium: The Takeda Oncology Company. The supplemental new drug application includes long-term overall survival data from the Phase 3 Vista trial, which examined treatment with Velcade in patients with previously untreated multiple myeloma. Applications granted priority review are approved by the FDA within six months instead of ten. For more information, please see the Millennium press release.

Celgene To Benefit From Increased Use Of Revlimid – Analysts believe that Celgene's stock may recover by the end of this year due to more doctors treating patients with Revlimid (lenalidomide). Revlimid is becoming more accepted as a maintenance treatment for multiple myeloma, lymphoma, and leukemia. Also, Celgene will report on a new clinical trial in December, which may raise sales. For more information, please see the Forbes article.

MMRF Chicago Marathon – On October 11 the Multiple Myeloma Research Foundation (MMRF) team will be taking part in the Bank of America Chicago Marathon. The MMRF is seeking contributions for its runners, which will go towards helping to fund multiple myeloma research. For more information, please visit the MMRF Web site.

For a more detailed listing of myeloma related events, please check the Myeloma Beacon Events Calendar.

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Research Confirms MGUS Is Linked To Myeloma, But May Not Be Linked To As Many Diseases As Previously Thought – According to a study published in the August 2009 issue of Mayo Clinic Proceedings, monoclonal gammopathy of undetermined significance (MGUS) may not be linked to as many serious diseases as previously thought. MGUS is a symptomless blood disorder that is a precursor of multiple myeloma. This study confirmed a link between MGUS and 14 diseases.  However, before this study, it was also thought to be a precursor for many more diseases. These Mayo Clinic findings may save patients from unnecessary tests and treatment. For more information, please see the Mayo Clinic press release.

Lawsuit Claims Celgene Corporation Misappropriated The Idea Behind Thalidomide – On August 24, Beth R. Jacobson filed a lawsuit against Celgene Corporation claiming “misappropriation of an idea” and “unjust enrichment” concerning the company’s sale of thalidomide (Thalomid) and Revlimid (lenalidomide) for the treatment of myeloma. The suit claims that Jacobson developed the original idea for treating myeloma with thalidomide and is consequently entitled to compensation based on established legal precedent. Jacobson seeks a minimum of $300 million in past damages and 25 percent of the future profits from the sale of Celgene’s thalidomide products. For more information, please see Ms. Jacobson's press release.

Light The Night Walks – On September 11, the Leukemia & Lymphoma Society (LLS) will hold Light the Night Walks in St. Louis and St. Peters, MO. Participants will walk along a two- or three-mile route, carrying a lighted balloon, in support of those touched by blood cancer. For more information, please visit the LLS Web sites for each of the events.

For a more detailed listing of myeloma related events, please check the Myeloma Beacon Events Calendar.

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Celgene Corporation reported yesterday that a Phase 3 clinical trial of Revlimid (lenalidomide) in first-line multiple myeloma patients has produced overwhelmingly positive results. The outcome of the trial, known as MM-015, suggests that Revlimid taken in combination with melphalan (Alkeran) and prednisone, followed by continuous Revlimid, produces significant improvement in progression-free survival.

While Revlimid is already prescribed as a front-line drug for multiple myeloma, it is approved for use only in patients for whom other treatments have failed. In the United States, it is also used off-label, meaning that …

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Lenalidomide (initially known as CC-5013 and marketed as Revlimid by Celgene) is a derivative of thalidomide introduced in 2004. It was initially intended as a treatment for multiple myeloma, for which thalidomide is an accepted therapeutic modality, but has also shown efficacy in the hematological disorders known as the myelodysplastic syndromes. [...]

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Thalidomide is a sedative-hypnotic, and multiple myeloma medication. The drug is a potent teratogen in rats, rabbits, and primates including humans: this means that severe birth defects may result if the drug is taken during pregnancy. [...]