Panobinostat could be the next potential myeloma therapy approved by the U.S. Food and Drug Administration (FDA).

Moreover, an approval decision related to the drug's potential marketing in the United States could be made by this fall.

In a surprisingly indirect manner, Novartis, the Swiss pharmaceutical com­pany that is developing pan­o­bino­stat (LBH589), announced this morn­ing that it has filed an application to have pan­o­bino­stat approved as a new drug by the FDA.

The announcement was indirect in the sense that Novartis did not actually say it has filed an application for …

Millennium: The Takeda Oncology Company announced today that the U.S Food and Drug Administration has approved subcutaneous administration of Velcade for the treatment of multiple myeloma and relapsed mantle cell lymphoma.

Velcade (bortezomib), which is marketed by Millennium and its parent company Takeda Pharmaceutical Company Limited (TSE:4502), is currently approved to be administered intravenously (infused into a vein).

The FDA decision to approve the subcutaneous administration of Velcade (injection into fat just below the skin, often abbreviated as subcu or subQ) was based on results of a Phase 3 study comparing subcutaneous …

Onyx Pharmaceuticals, the U.S. com­pany developing car­filz­o­mib as a potential new treat­ment for multiple myeloma, announced earlier today that the U.S. Food and Drug Administration (FDA) has granted "standard review designation" to the com­pany's New Drug Applica­tion for car­filz­o­mib.

This means that the FDA expects to make a decision by July 27, 2012, on Onyx's application to market carfilzomib (Kyprolis) in the United States.

The announcement is a disappointment for Onyx, which had hoped to receive a so-called "priority review" of the car­filz­o­mib application.

The target FDA review time for applications granted …

Onyx Pharmaceuticals, the U.S. com­pany developing car­filz­o­mib as a potential new treat­ment for multiple myeloma, announced this morning that the U.S. Food and Drug Administration (FDA) has accepted the com­pany's New Drug Applica­tion for car­filz­o­mib.

The announcement means that the FDA will now begin its full review of carfilzomib (Kyprolis).

The length of time required for that review depends on whether the FDA grants the drug what is known as "priority review."

If car­filz­o­mib is granted priority review, the FDA will aim to make a decision on the application by the …

Onyx Pharmaceuticals announced this morning that it has completed submission of its application to the U.S. Food and Drug Administration (FDA) for the approval of carfilzomib (Kyprolis) as a treat­ment for re­lapsed and refractory multiple myeloma.

Onyx began submitting the application in January after the FDA granted car­filz­o­mib "Fast Track" status, which expedites the review process by allowing the submission of application materials on a rolling basis.  The com­pany has requested priority review of the car­filz­o­mib application, which, if granted by the FDA, could allow the drug to be launched in the …

A group of mainly European multiple myeloma researchers has issued a statement regarding the potential link between Revlimid and secondary cancer.

According to the statement, the group initially met in Paris on February 23, 2011 at a meeting arranged by Celgene, the company that developed and markets Revlimid (lenalidomide).

The group includes 12 well-known multiple myeloma researchers, almost entirely from Europe. Among the group's members are investigators from the CALGB 100104, IFM 2005-02, and MM-015 clinical trials, which are the three trials that last December reported data suggesting a possible connection between …

The U.S. Food and Drug Administration announced today that it approved Amgen’s Xgeva to help prevent fractures and to slow bone disease in patients with solid tumors that have spread to and caused damage to bone. Xgeva was not approved, however, for multiple myeloma patients with bone damage.

Xgeva is the new brand name given to denosumab when used for the treatment of cancer-related bone disease. Denosumab at lower doses is marketed under the brand name Prolia for the treatment of postmenopausal women with osteoporosis and a high risk of bone fractures. …