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Tagrisso

AstraZeneca ends month with two pieces of news

AstraZeneca has ended the month with more positive news on Tagrisso, that had previously been approved in China under its Priority Review, as it achieved FDA approval in a particular indication of non-small cell lung cancer (NSCLC). Beyond this, AstraZeneca also announced that it had sold the commercial rights to Zoladex, in the US and Canada, to TerSera Therapeutics for $250 million – with a potential further $70 million possible in milestone payments.

AstraZeneca's medicine approved under China’s Priority Review

AstraZeneca has been boosted by the news that its drug, Tagrisso, has become its first drug to be approved under China’s new Priority Review pathway. The approval comes in a particular indication of non-small cell lung cancer (NSCLC) and opens further avenues for AstraZeneca’s into the lung cancer market in China, with its drug Iressa already on the market.

AZ lung cancer drug cuts disease progression by 70%

AstraZeneca is touting its cancer drug Tagrisso (osimertinib) as a potential new standard of care for epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), ousting chemotherapy as new data revealed from a recent Phase 3 trial showed that the treatment reduced risk of disease progression by 70%.

AstraZeneca’s wins major drug approval by NICE

AstraZeneca’s Tagrisso (osimertinib) has successfully received endorsement of Britain’s Cancer Drugs Fund that has a reserve of £340 million to fund drugs deemed cost efficient and with evidence of positive results from clinical trials. Tagrisso is the first drug to be approved by the NHS through the newly reformed fund. To achieve this back, AstraZeneca had to demonstrate to the fund, through clinical evidence, that the drug was particularly effective and to provide a discount on the list price for the drug.

Hanmi Pharma shares crash after shock contract termination

News broke on 29 September that Hanmi Pharma, South Korea’s leading drug maker, had signed a $910 million deal with US-based Genentech for the technology required to make a cancer drug. Shares rose considerably on the news only to be hit by the news on the following morning that Boehringer Ingelheim will return its license of HM61713 to the South Korean company.

AstraZeneca presents positive Phase III results for lung cancer drug Tagrisso

AstraZeneca has presented results from the latest Phase III trial evaluating Tagrisso (osimertinib) as a second line treatment for patients with a specific kind of non-small cell lung cancer (NSCLC) which demonstrated superior progression-free survival compared to standard platinum-based doublet chemotherapy.

In the AURA3 trial, more than 400 patients with EGFR T790m mutation positive, locally-advanced or metastatic NSCLS, whose disease had progressed following first line EGFR tyrosine kinase inhibitor therapy, received Tagrisso.

Chi-Med to get $10 million milestone from AstraZeneca after initiation of expanded Phase II trials in NSCLC

Hutchison China MediTech (Nasdaq: HCM) on Monday said it is expanding Phase II trials in non-small cell lung cancer to include the selective c-Met inhibitor savolitinib. 

The initiation of the expanded Phase II study has triggered a $10 million milestone payment to Hutchison MediPharma, a unit of Chi-Med, under the terms of the agreement with UK drugmaker AstraZeneca (LSE: AZN). 

Japanese approval for AZ lung cancer drug

AstraZeneca’s Tagrisso (osimertinib) has been approved in Japan for the treatment of a specific form of clung cancer.

Japanese regulator, the Ministry of Health, Labour and Welfare (MHLW), approved the drug for patients with epidermal growth factor receptor (EGFR) T790M mutation-positive inoperable or recurrent non-small cell lung cancer (NSCLC) that is resistant to EGFR tyrosine kinase inhibitor (TKI) therapy.

AstraZeneca’s Tagrisso gets EU lung cancer sign-off

AZ sign

The European Commission (EC) has granted conditional marketing authorisation to AstraZeneca’s Tagrisso to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) that tests positive a specific mutation.

Tagrisso (AZD9291, osimertinib) is the first medicine indicated for patients with epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC. Mutations in the EGFR receptor can lead to uncontrolled cell growth and tumour formation.

AstraZeneca earns ‘speedy’ FDA approval for lung cancer drug

AstraZeneca chief executive Pascal Soriot

The FDA has approved AstraZeneca’s new lung cancer drug Tagrisso, in a record two and half years from development, under the regulator’s accelerated approval pathway.

Tagrisso (AZD9291) is a once-daily tablet patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose cancer has progressed while they have been on or after treatment with an EGFR tyrosine kinase inhibitor (TKI) therapy.

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