Back in 2015, AstraZeneca’s Tagrissso was given landmark approval from the US Food and Drug Administration (FDA) following the results from its phase 3 Aura trial.
A significant advancement in the treatment of metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).
The T790M mutation is most commonly found in cases of NSCLC carrying a TKI-sensitive EGFR mutation that have developed resistance after TKI treatment.
Tagrisso is projected to be a central contributor to AstraZeneca’s portfolio, with anticipated sales surpassing $7 billion and a 48% market share of small molecules in lung cancer treatment by 2029, GlobalData says.
The analytics company’s patient-based forecasts indicate a robust demand for small molecules in the treatment of NSCLC in the eight major markets – the US, France, Germany, Italy, Spain, UK, Japan, and China, projecting the market to reach over $15 billion by 2029, representing approximately 40% of the total NSCLC market.
Biswajit Podder, oncology and hematology analyst said: “Tagrisso’s approval marked a paradigm shift in the treatment of lung cancer, especially in the early stages where tumor resection is possible but recurrence is common (phase 3 Adaura trial). In addition, the groundbreaking results of the phase 3 Flaura trial added a new standard to the first-line treatment of EGFR-mutated NSCLC. This ensures that a wider spectrum of patients can reap the benefits of targeted small-molecule medicines like Tagrisso.”
Roche is expected to secure the second position with projected sales of over $2.5 billion and a market share of 17%, while Amgen is anticipated to follow closely, holding the third position with projected sales of over $1 billion and a market share of 7.3%.
GlobalData reveals that a total of 39 small molecules have been commercialized for the treatment of lung cancer, with a total of 4,951 ongoing Phase III trials employing 34 distinct small molecules globally. In addition, 14 new small molecules for the treatment of lung cancer are currently undergoing Phase III clinical trials, indicating a robust and dynamic clinical trial landscape.
Podder added: “In addition to the success of Tagrisso, the other promising pipeline drugs of AstraZeneca, particularly Orpathys, are contributing to the company’s small-molecule lung cancer treatment portfolio.
“It is anticipated to generate $361 million in sales for lung cancer treatment by 2029. Furthermore, Lynparza, another small molecule from AstraZeneca, is undergoing clinical trials for the treatment of lung cancer. However, Eisai and Merck’s new asset, Kisplyx/Lenvima, is another major small molecule in Phase III development for the treatment of NSCLC, with projected sales of $176 million by 2029.’’