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NICE backs Roche’s Gazyvaro, Pfizer’s Lorviqua in new guidance

The two new cancer drugs will treat follicular lymphoma and lung cancer


Cost-effectiveness watchdog NICE has recommended routine NHS funding in England for two new cancer drugs – Roche’s Gazyvaro for follicular lymphoma (FL) and Pfizer’s lung cancer therapy Lorviqua.

Gazyvaro (obinutuzumab) has been cleared as part of a treatment regimen with bendamustine – followed by Gazyvaro alone as a maintenance therapy – for FL patients who have relapsed after first-line treatment with rituximab, with alone or with other drugs.

Roche’s drug has been recommended by NICE for routine NHS alongside chemotherapy as a first-line treatment for advanced FL since 2018, having been rejected earlier on the grounds it was too expensive.

At the time, NICE said second-line, maintenance use of the drug should be covered by the Cancer Drugs Fund (CDF) rather than the NHS’ regular budget as the evidence for the drug’s benefits in this setting wasn’t sufficiently strong.

Now, the agency says it has updated the guidance because limited experience from the CDF “appears to support the clinical trial evidence” that adding Gazyvaro to bendamustine in relapsed patients “improves how long people have before their disease progresses and how long they live”.

Gazyvaro has been approved in Europe since 2014 as a follow-up to rituximab, which Roche markets as MabThera but now has multiple biosimilars available. It has been designed with sugar molecule side chains that the company says improve its therapeutic and safety profile.

Lorviqua (lorlatinib) has meanwhile been recommended by NICE in final guidance as an option for treating patients with ALK-positive non-small cell lung cancer (NSCLC) whose disease has progressed after first-line treatment with Alecensa (alectinib) or Zykadia (ceritinib, as well as Pfizer’s Xalkori (crizotinib) and at least one other ALK inhibitor.

Lorviqua hasn’t been compared directly with other drugs. However, indirect comparisons with platinum doublet chemotherapy and the regimen of Roche’s Tecentriq (atezolizumab) plus bevacizumab, carboplatin and paclitaxel (ABCP) – the standard second-line treatment options after Alecensa and Zykadia – suggest Lorviqua can improve disease progression and survival.

As  result, the drug “meets NICE's criteria to be considered a life-extending treatment at the end of life”, the organisation said, and added that while cost-effectiveness remains uncertain, it is likely to be within the acceptable range.

Lorviqua was granted conditional approval by the EMA last year, and according to Pfizer was specifically designed to tackle advanced NSCLC tumours that have spread to other areas of the body, particularly the brain.

Article by
Phil Taylor

13th May 2020

From: Research



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