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LOS ANGELES, June 20 (Reuters) - Takeda Pharmaceutical Co 4502.T, Japan's largest drugmaker, won U.S. approval to promote its cancer drug Velcade for earlier treatment of multiple myeloma, the company said on Friday.
The Food and Drug Administration approved Velcade for patients newly diagnosed with the blood cancer. The drug had previously been cleared for multiple myeloma patients who had received at least one prior therapy.
Takeda acquired Velcade through its recent takeover of Boston-based Millennium Pharmaceuticals. Johnson & Johnson JNJ.N co-develops the drug, which is known generically as bortezomib.
The latest FDA approval was based on an international clinical trial which found that 30 percent of previously-untreated patients had complete remission of their cancer after receiving Velcade, compared with 4 percent of patients treated with standard therapy.
The most common side effects seen in the trial included decreased blood platelets, decreased levels of white blood cells, nausea, peripheral nerve pain, diarrhea and anemia.
Multiple myeloma is the second most common hematological cancer. There were more than 56,000 Americans living with the disease as of 2005, the latest year for which statistics are available, according to the Multiple Myeloma Research Foundation.
Analysts expected the FDA approval of Velcade as an initial therapy for the blood cancer. The drug is now slated to compete against Celgene Corp's CELG.O Thalomid for market share in the treatment of newly-diagnosed multiple myeloma patients.
Mitsubishi UFJ Securities analyst Yasuhsiro Nakasawa said in a research note earlier this month that he also expects the drug to be approved in 2011 as a treatment for lymphoma, a cancer involving cells of the immune system.
“We expect U.S. sales of Velcade to reach $1 billion in five to six years’ time as a result of additional indications and buildup of clinical trial results,” he said.
The drug had global sales of $800 million last year.
Reporting by Deena Beasley and Lisa Richwine; editing by Carol Bishopric
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