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Tagrisso

No NICE recommendation for AstraZeneca's Tagrisso in EGFR+ lung cancer

AstraZeneca’s Tagrisso (osimertinib) has been knocked back for routine use on the NHS in England and Wales by the drug watchdog NICE in the treatment of previously treated, locally advanced or metastatic epidermal growth factor receptor (EGFR)-positive non-small-cell lung cancer (NSCLC).

The decision is a reinforcement of one made in July last year after AstraZeneca appealed against the rejection.

AZ's Tagrisso extends median overall survival by over 3 years in metastatic, EGFR-mutated lung cancer

AstraZeneca took to the stage at the 2019 European Society for Medical Oncology (ESMO) Congress in Barcelona to present new data on Tagrisso (osimertinib) in the first-line treatment of locally-advanced or metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC).

Tagrisso was shown to present a “statistically significant and clinically meaningful improvement” in overall survival, extending life by a median of 38.6 months compared to 31.8 months with previous standards of care gefitinib and erlotinib.

AZ's Tagrisso secures China approval in first-line advanced lung cancer

AstraZeneca’s Tagrisso (osimertinib) has secured approval in China from the country’s National Medical Products Administration (NMPA) in the first-line treatment of locally-advanced or metastatic non-small cell lung cancer (NSCLC), it has emerged.

The authorisation, achieved via the Priority Review Pathway, covers adult patients whose tumours have the genetic mutations of epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitutions.

AstraZeneca's Tagrisso improves overall survival in lung cancer in Phase 3 trial

AstraZeneca has said its cancer drug Tagrisso significantly improved overall survival in a Phase 3 study of patients with lung cancer.

The drug showed statistically significant and clinically meaningful improvement in overall survival in previously untreated patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations.

Japan approves AstraZeneca's Tagrisso in EGFRm non-small cell lung cancer

AstraZeneca has revealed that its EGFR tyrosine kinase inhibitor Tagrisso (osimertinib) has been approved in Japan by the nation’s Ministry of Health, Labour and Welfare (MHLW) as a first-line therapy in patients with inoperable or recurrent epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).

The decision, made under priority review, was based on evidence generated from the Phase 3 FLAURA trial, which pitted Tagrisso against the first-line EGFR TKIs erlotinib or gefitinib in treatment-naïve patients with locally-advacned or metastatic EGFR-

EU gives nod to expanded label for AZ’s Tagrisso

AstraZeneca has scored another success with Tagrisso in Europe, by receiving an expanded marketing authorisation for Tagrisso in the first-line setting for patients with locally-advanced or metastatic non-small cell lung cancer, with activating epidermal growth factor receptor mutations.

The approval comes on the back of data from trials showed that Tagrisso was able to reduce risk of disease progression or death by 54% when compared against standard treatment.

AZ's Tagrisso gets FDA nod in first-line EGFR-mutated lung cancer

AstraZeneca has announced that its epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) Tagrisso (osimertinib) has received approval from the FDA for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in patients whose tumours have EGFR mutations, specifically exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

Hanmi terminates lung cancer drug after being muscled out by AZ's Tagrisso

South Korea’s Hanmi Pharmaceutical has announced its intention to terminate development of its lung cancer drug Olita (olmutinib) as it admits that circumstances within the space have meant that continued R&D costs would “eclipse its value”.

“We found it difficult to find participants for our clinical studies because there is a medication that has already completed global phase 3 trials and is covered by insurance,” a spokesperson for the company said.

AstraZeneca's Tagrisso beats standard of care in halting NSCLC

AstraZeneca has revealed new data at the European Society of Medical Oncology (ESMO) on the efficacy of Tagrisso (osimertinib) in the first-line treatment of epidermal growth factor receptor (EGFR)-mutated non-small-cell lung cancer (NSCLC) in adult patients. Compared to the current standard of therapy – erlotinib, manufactured by Roche and Astellas, orAstraZeneca’s own Iressa (gefitinib) – Tagrisso was found to extend progression-free survival (PFS) by 54%.

AZ's Tagrisso continues successes with EU approval

More good news for AstraZeneca’s Tagrisso (osimertinib), as the company announces that the European Commission has granted the drug full marketing authorisation for the treatment of locally-advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC) in adult patients.

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