Trial results back NICE decision on Novartis cancer drug
pharmafile | April 15, 2015 | News story | Sales and Marketing | Arzerra, Cancer, NHS, NICE, chemo, chlorambucil, fludarabine, leukaemia, ofatumumab
Treatment with Arzerra improves survival in people with chronic lymphocytic leukaemia (CLL) according to study results that back NICE’s decision to recommend the Novartis drug.
A Phase III study looked at 477 people with CLL in 16 countries that had not previously received treatment, and were not able to have the current standard therapy fludarabine because of their age (the average in the study was 69 years) or existing health problems. These were given either Arzerra (ofatumumab) in combination with chemotherapy drug chlorambucil, or chlorambucil alone.
By the end of the study people who took the Arzerra combination survived for a median of 22.4 months with no worsening of their cancer, compared to 13.1 months in people who took chlorambucil alone.
However, half of the patients in the Arzerra group had adverse events compared to the chlorambucil group (43%), most commonly being that of neutropenia.
NICE has issued a final appraisal determination backing Arzerra, which was originally a GSK drug but is now jointly marketed by Genmab and Novartis after the Swiss firm swapped oncology and vaccine assets with GSK. The guidance is due out in May.
Published in The Lancet the study’s lead author Professor Peter Hillmen from St. James’s University Hospital in Leeds, says: “Finding effective treatments with clinically acceptable safety profiles for elderly patients with CLL and for those with co-existent chronic and potentially life-threatening conditions continues to be a challenge.
“The results reinforce our understanding that the combination of ofatumumab plus chlorambucil provides this patient population a treatment option that improves clinical health outcomes in CLL.”
Alessandro Riva, global head of Novartis oncology development and medical affairs, adds: “The results demonstrate that the addition of Arzerra to chlorambucil resulted in a significant improvement in progression free survival, with an acceptable safety profile. We are excited that Arzerra is now part of the Novartis oncology portfolio of products, and look forward to building upon the body of evidence that supports the clinical benefit of Arzerra for appropriate patients with CLL.”
Teva files CLL infusion
Meanwhile Teva has filed a new drug application with the FDA for another CLL treatment, liquid bendamustine hydrochloride (HCl) rapid infusion. It received orphan drug status from the US regulator – and therefore may be eligible for seven years of exclusivity if approved – as a treatment for patients with CLL, and those with indolent B-cell non-Hodgkin lymphoma that has progressed despite at least six months of treatment with Roche’s Mabthera (rituximab).
“We are very pleased the FDA has accepted the rapid infusion bendamustine NDA for review,” says Paul Rittman, vice president and general manager of Teva oncology. “Teva looks forward to the opportunity to bring this product to market, if approved, and we believe it represents an important and improved benefit to both patients and healthcare providers.”
Lilian Anekwe
Related Content
A community-first future: which pathways will get us there?
In the final Gateway to Local Adoption article of 2025, Visions4Health caught up with Julian …
The Pharma Files: with Dr Ewen Cameron, Chief Executive of West Suffolk NHS Foundation Trust
Pharmafile chats with Dr Ewen Cameron, Chief Executive of West Suffolk NHS Foundation Trust, about …
Is this an Oppenheimer moment for the life sciences industry?
By Sabina Syed, Managing Director at Visions4Health In the history of science, few initiatives demonstrate …
