AZ appeals against NICE rejection of Tagrisso in untreated lung cancer

Pharmaphorum | July 05, 2019

AZ appeals against NICE rejection of Tagrisso in untreated lung cancer
AstraZeneca is appealing against NICEs decision not to recommend funding for its lung cancer drug Tagrisso (osimertinib) in untreated patients with epidermal growth factor receptor (EGFR) mutations. In final draft guidance, NICE said it had rejected regular NHS funding for Tagrisso, because the survival benefits compared with standard treatment such as AZ’s older drug Iressa (gefitinib) are unclear in first-line non-small cell lung cancer. Tagrisso has been the driving force behind AZ’s sales recovery after a steep patent cliff – it generated $630 million in Q1 alone and is the company’s top selling drug after first approval in 2015 in a more advanced form of the disease.
NICE had been considering results from the FLAURA trial, comparing Tagrisso with Roche’s Tarceva (erlotinib) and AZ’s Iressa (gefitinib) in untreated patients. Patients in the trial had either exon 19 deletion (del19) or exon 21 (L858R) mutations, accounting for around 90% of EGFR mutations. NICE said it noted progression-free survival was 18.9 months on Tagrisso compared with 10.2 months on standard care. Overall survival data is not mature but data gathered so far show that Tagrisso will likely extend this too. However NICE is concerned that data so far do not show the size of treatment benefits, and that AZ’s economic model does not fully capture the benefits of subsequent treatments.

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This article is part of a series on Corporate law Society.svg By jurisdiction[show] General corporate forms[show] Corporate forms by jurisdiction[show] Doctrines[show] Related areas[show] Company portal Law portal v t e A company, abbreviated as co., is a legal entity made up of an association of people, be they natural, legal, or a mixture of both, for carrying on a commercial or industrial enterprise. Company members share a common purpose, and unite in order to focus their various talents and organize their collectively available skills or resources to achieve specific, declared goals. Companies take various forms, such as: voluntary associations, which may include nonprofit organizations business entities with an aim of gaining a profit financial entities and banks A company or association of persons can be created at law as a legal person so that the company in itself can accept limited liability for civil responsibility and taxation incurred as members perform (or fail to discharge) their duty within the publicly declared "birth certificate" or published policy. Companies as legal persons may associate and register themselves collectively as other companies – often known as a corporate group. When a company closes, it may need a "death certificate" to avoid further legal obligations.


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RESEARCH

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Hemogenyx Pharmaceuticals plc | January 13, 2022

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PHARMACY MARKET

Nobel Biocare Receives FDA 510(k) Clearance for the Nobel Biocare N1™ Implant System

Envista Holdings Corporation | December 28, 2021

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BUSINESS INSIGHTS

Arrowhead Initiates Project to Build New Manufacturing and Lab Facilities

Arrowhead Pharmaceuticals | December 21, 2021

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PHARMA TECH

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Milestone Scientific, Inc. | December 24, 2021

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Spotlight

This article is part of a series on Corporate law Society.svg By jurisdiction[show] General corporate forms[show] Corporate forms by jurisdiction[show] Doctrines[show] Related areas[show] Company portal Law portal v t e A company, abbreviated as co., is a legal entity made up of an association of people, be they natural, legal, or a mixture of both, for carrying on a commercial or industrial enterprise. Company members share a common purpose, and unite in order to focus their various talents and organize their collectively available skills or resources to achieve specific, declared goals. Companies take various forms, such as: voluntary associations, which may include nonprofit organizations business entities with an aim of gaining a profit financial entities and banks A company or association of persons can be created at law as a legal person so that the company in itself can accept limited liability for civil responsibility and taxation incurred as members perform (or fail to discharge) their duty within the publicly declared "birth certificate" or published policy. Companies as legal persons may associate and register themselves collectively as other companies – often known as a corporate group. When a company closes, it may need a "death certificate" to avoid further legal obligations.

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