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June 1, 2014
14:24 EDTJNJ, TKPYYVelcade-based therapy 'significantly' improved progression-free survival
Millennium: The Takeda Oncology Company (TKPYY) announced results from the primary analysis of an international, randomized Phase 3 study that showed treatment with a VELCADE, bortezomib-based combination therapy demonstrated a 59% relative improvement in the study’s primary endpoint of progression-free survival among previously untreated patients with mantle cell lymphoma, MCL, compared to treatment with a standard therapy. These data were presented today at the annual meeting of the American Society of Clinical Oncology, ASCO. After a median follow up of 40 months, median overall survival, OS, a key secondary endpoint, had not been reached for patients who received the VELCADE-based therapy, while a median OS of 56.3 months was observed in patients treated with the standard regimen. Overall, among patients receiving VcR-CAP compared to R-CHOP, serious adverse events, SAEs, were reported in 38% vs. 30% of patients, and grade =3 adverse events were reported in 93% vs. 85% of patients. “The 59% relative improvement in progression-free survival, along with the trend suggesting improved OS with the VELCADE-based regimen, has the potential to represent a significant advance in the frontline treatment of mantle cell lymphoma for some patients,” said Michael Vasconcelles, MD, Global Head, Takeda Oncology Therapeutic Area Unit. “Patients with relapsed MCL have benefited from access to VELCADE therapy since 2006. We look forward to working with regulatory authorities to bring this new information to physicians and patients in the near future.” VELCADE is co-developed by Millennium/Takeda and Janssen Pharmaceutical Companies (JNJ).
News For TKPYY;JNJ From The Last 14 Days
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June 23, 2015
13:10 EDTTKPYYNestle appoints Takeda’s Roger as CFO, effective July 1
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June 17, 2015
07:21 EDTJNJGeneric ADHD drugs still sold despite FDA non-equivalance finding, NYT reports
The FDA announced last November that two generic versions of Johnson & Johnson's (JNJ) Concerta ADHD drug, one made by Mallinckrodt (MNK) and the other by UCB, could no longer be considered the equivalent of the branded drug after tests and analyses suggested that their effectiveness began to wear off much more quickly, but the drugs are still being sold despite an FDA mandated deadline having passed for the companies to either prove the drugs were equivalent or remove them from the market, said The New York Times. The report noted a third generic product, sold by Actavis (AGN), was found to be equivalent to the branded Concerta. Reference Link

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