Takeda eyes new drug licences following positive blood cancer studies
pharmafile | December 11, 2014 | News story | Research and Development, Sales and Marketing | Adcetris, Takeda, Velcade, ash, bortezomib, brentuximab vedotin, hematology
Takeda is bringing its biotech arm in-house to create a global oncology business unit, which it says will drive forward its applications for new cancer drugs with the EMA in the next two years.
Takeda purchased Millennium, a biotech company based in the US, in 2009, but will retire the brand and instead integrate its R&D structure within Takeda.
In an interview with Pharmafile at the American Hematology Society conference in San Francisco, Dr Michael Vasconcelles who is the head of the oncology therapeutic area unit, said the move is driven by their need to bring the marketing of cancer drugs ‘completely under Takeda’s domain’.
“Our commercial business unit has historically been focussed primarily on the US business. But given the growing commercial success of Velcade (bortezomib) and our success outside the US with Adcetris (brentuximab vedotin), we need to take that model from the US business and build a global oncology business unit within Takeda.
“We have multiple products in our oncology portfolio but none of them are completely global under Takeda’s domain with respect to commercialisation, they each have certain geographic partnerships. But now we have a clear global footprint it made sense to build that global commercial infrastructure.”
Takeda presented studies at the conference that it will use for new EMA submissions for Adcetris in post-transplant patients with Hodgkins’ lymphoma, and the new multiple myeloma drug ixazomib.
The AETHERA trial included 329 patients with Hodgkin lymphoma who were at risk of relapse following a stem cell transplant. It found patients who were treated with Adcetris after their transplant had longer progression-free survival than patients who received placebo.
“It’s the first RCT with Adcetris where the data has been good”, Vasconcelles says. “The data shows very nicely that progression-free survival following transplant is markedly improved in patients who are treated with Adcetris, for about a year after transplant.
“That’s important because it has the potential for establishing a new scheme of care for those patients with risk factors who undergo a transplant. It can prolong their clinical situation without any evidence of their Hodgkin returning or in some cases not coming back at all.”
New direction of travel for cancer drugs
Meanwhile a Phase II study of the proteasome inhibitor ixazomib in 50 patients with multiple myeloma found that ixazomib can be used as a maintenance therapy alone, after initial treatment with Revlimid (lenalidomide) and dexamethasone.
Proteasome inhibitors are key therapies for multiple myeloma, with others also showing potential in this area. Onyx Pharmaceutical presented Phase III data at the same conference that found Kyprolis’ (carfilzomib) is effective in patients with relapsed or treatment-resistant multiple myeloma.
“Ixazomib is a very interesting compound” Vasconcelles says. “It’s a proteasome inhibitor, and there’s already some available for patients, but they have some limitations with their administration and the side effect profile that emerges over time. To be able to give a proteasome inhibitor for an extended period of time was a key objective of our development programme. So this is, we think, one important piece in that step-wise approach to demonstrating benefits for patients.”
Having marketed Velcade for a decade, Vasconcelles says proteasome inhibitors may be ‘the direction of future travel’ for multiple myeloma and allow the company to replicate the success in multiple myeloma it has seen with Velcade.
“Proteasome inhibitors really are foundational to therapies, so we are looking for ways to safely and effectively provide them for patients in a way that enhances what is currently exists. Even though this is relatively small numbers at this point, I think this study provides a proof of principle for many developing programs that we have ongoing now in Phase III.”
Takeda has ongoing Phase III studies which will form the basis of EMA submissions in the next two years, Vasconcelles says.
“The first of the ixazomib studies is currently in the relapsed setting; we expect to potentially have top line data in 2015, and given the regulatory path in Europe then it would be possibility to – in the setting of positive trial results – have ixazomib approved and eventually available in 2016.
“With respect to Adcetris, it’s already approved and available [Hodgkin lymphoma and anaplastic large cell lymphoma in the relapsed and refractory setting]. With this data we would expect to file extended licence applications with European regulatory agencies in 2015.”
Lilian Anekwe
Related Content
MHRA approves Takeda’s Hyqvia for chronic inflammatory demyelinating polyneuropathy treatment
Takeda has announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing …
Takeda and ImmunoGen collaborate for development and commercialisation of Elahere in Japan
ImmunoGen has announced that it has entered into an exclusive collaboration with Takeda Pharmaceutical Company …
Takeda and HUTCHMED’s cancer drug shown to prolong overall survival
Clinical trial data from a study into the metastatic colorectal cancer (CRC) drug fruquintinib, which …
