dm+d

32704011000001105

New Medicines

TagrissoEGFR-positive non-small cell lung cancer (NSCLC) in adults - adjuvant therapy

Information

Tagrisso
Licence extension / variation
AstraZeneca
AstraZeneca

Development and Regulatory status

Launched
Launched
Launched
May 21Approved in EU [20].
May 21MHRA approves osimertinib for adjuvant treatment of early-stage lung cancer. Exact indication not stated but presume identical to the EU approved licence. This is the first MHRA authorisation under Project Orbis, a scheme which it joined in January. Project Orbis is an innovative programme coordinated by the US FDA with Canada, Australia, Switzerland, Singapore, Brazil and the UK as other participants. The programme has been set up to allow participating partners to review and approve applications for promising cancer treatments quickly and efficiently. NHS England, NICE and AstraZeneca have reached an agreement to enable early access to osimertinib for early-stage lung cancer patients in England on a budget-neutral basis to the NHS while NICE undertakes its appraisal [19].
Apr 21Recommended for EU approval by CHMP - the additional indication is for "the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.” [18]
Dec 20Has been filed in the EU [17].
Dec 20FDA has approved Tagrisso (osimertinib) as the first adjuvant treatment for patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation (EGFR mutation) [15].
Nov 20EU filing planned for Q4 20 [14].
Oct 20Granted priority review in US [13].
Apr 20Following the early unblinding of the ADAURA trial, plans for regulatory submission are now underway [10].
Sep 19Filings not expected until at least 2021 [9].
Sep 18Filings based on ADAURA trial planned for 2020 or later [6].
Nov 16Filings still predicted in 2022 [4].
Dec 15Pivotal PIII ADAURA study starts. EU & US filings planned for 2022 [1].

Category

A 3rd-generation tyrosine kinase inhibitor targeting EGFR and T790M mutation positive tumours through the inhibition of EGFR.
In 2011 there were approximately 43,500 new diagnoses. Approximately 87% of lung cancers are NSCLC and approximately 10-15% of people with NSCLC have EGFR positive cancer
EGFR-positive non-small cell lung cancer (NSCLC) in adults - adjuvant therapy
Oral

Further information

Yes

Trial or other data

Oct 20PIII ADAURA continues to collect data but collection of primary outcome data completed in Jan 20 [16].
Sep 20PIII ADAURA trial (NCT02511106) of 682 patients with stage IB to IIIA EGFR mutation–positive non–small-cell lung cancer, reported longer disease-free survival at 24 months among those who received osimertinib vs placebo (90% vs 44%; HR, 0.17; 99% CI, 0.11 to 0.26; P<0.001) with no new safety concerns [12].
May 20AstraZeneca announce topline results from PIII ADAURA study. Adjuvant osimertinib was associated with improved disease-free survival in early-stage EGFR-mutated NSCLC, with 89% alive and disease-free at 2 years vs 53% with placebo [11].
Apr 20At the recommendation of an independent data monitoring committee, AstraZeneca will unblind the ADAURA trial 2 years ahead of schedule after the drug posted a significant benefit in the primary endpoint of disease-free survival (DFS). The trial will continue to assess the secondary endpoint of overall survival [10].
Dec 19PIII ADAURA study has finished recruiting; collection of primary outcome data now predicted to complete Feb 22 [8].
Nov 18PIII ADAURA (NCT02511106) is still recruiting; collection of primary outcome data now predicted to complete Jan 22 [7].
Oct 17PIII ADAURA (NCT02511106) is still recruiting; collection of primary outcome data now expected to complete Dec 21 [5].
Dec 16PIII ADAURA study (NCT02511106) is currently recruiting pts; collection of primary outcome data now expected Jul 17 [3].
Oct 15PIII ADAURA (NCT02511106) study to assess the efficacy and safety of AZD9291 versus Placebo, in 700 adults with Epidermal Growth Factor Receptor Mutation Positive stage IB-IIIA non-small cell lung carcinoma, following complete tumour resection with or without adjuvant chemotherapy starts. This global study will recruit patients from 210 locations worldwide including in the US & EU. Primary outcome is disease-free survival; collection of these data should complete Aug 2021 [2].

Evidence based evaluations

TagrissoLocally advanced, unresectable, EGFR-positive stage III Non-small cell lung cancer (NSCLC) in adults whose disease has not progressed following platinum-based chemoradiation therapy

Information

Tagrisso
Licence extension / variation
AstraZeneca
AstraZeneca

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

Third-generation tyrosine kinase inhibitor targeting EGFR and T790M mutation positive tumours.
In 2015, around 33,000 people were estimated to be diagnosed with NSCLC in England; around 21% had stage III disease. NICE clinical guideline 121 (CG121) recommends chemoradiotherapy as an option for people with stage II or III unresectable non-small-cell lung cancer [1].
Locally advanced, unresectable, EGFR-positive stage III Non-small cell lung cancer (NSCLC) in adults whose disease has not progressed following platinum-based chemoradiation therapy
Oral

TagrissoAdvanced EGFR mutation-positive non-small cell lung cancer (NSCLC) - first-line in combination with pemetrexed and carbo/cisplatin

Information

Tagrisso
Licence extension / variation
AstraZeneca
AstraZeneca

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

A 3rd-generation tyrosine kinase inhibitor targeting EGFR and T790M mutation positive tumours through the inhibition of EGFR.
In 2011 there were approximately 43,500 new diagnoses. Approximately 87% of lung cancers are NSCLC and approximately 10-15% of people with NSCLC have EGFR positive cancer. It is estimated that 450 patients per year in England are eligible for first line treatment of locally advanced or metastatic EGFR-TK mutation positive NSCLC.
Advanced EGFR mutation-positive non-small cell lung cancer (NSCLC) - first-line in combination with pemetrexed and carbo/cisplatin
Oral

Tagrisso Stage II/III resectable EGFR-positive non-small cell lung cancer (NSCLC) - neoadjuvant therapy with or without chemotherapy

Information

Tagrisso
Licence extension / variation
AstraZeneca
AstraZeneca

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

A 3rd-generation tyrosine kinase inhibitor targeting EGFR and T790M mutation positive tumours through the inhibition of EGFR.
In 2011 there were approximately 43,500 new diagnoses. Approximately 87% of lung cancers are NSCLC and approximately 10-15% of people with NSCLC have EGFR positive cancer. It is estimated that 450 patients per year in England are eligible for first line treatment of locally advanced or metastatic EGFR-TK mutation positive NSCLC.
Stage II/III resectable EGFR-positive non-small cell lung cancer (NSCLC) - neoadjuvant therapy with or without chemotherapy
Oral