AstraZeneca has received approval from the Central Drugs Standard Control Organisation (CDSCO) for the import, sale, and distribution of durvalumab in two formulations: 120 mg/2.4 mL and 500 mg/10 mL solution for infusion.
This authorization is specifically for the treatment of patients diagnosed with limited-stage small cell lung cancer (LS-SCLC) whose disease has remained stable following platinum-based chemoradiotherapy (CRT).
Durvalumab now stands as the sole approved consolidation therapy for LS-SCLC patients who have completed CRT, marking a significant advancement in the treatment landscape of this aggressive form of lung cancer, which accounts for roughly 15% of all lung cancer cases. While the majority of SCLC cases are identified at advanced stages, around 25% of patients in India are diagnosed with LS-SCLC, emphasizing the critical need for improved treatment options at an early stage.
According to data from GLOBOCAN 2022, lung cancer ranks as the fourth most common cause of cancer-related deaths in India. Traditionally, LS-SCLC treatment was limited to platinum-based CRT. However, findings from the ADRIATIC clinical trial, which included Indian patients, revealed that administering Durvalumab following CRT significantly enhances both progression-free survival and overall survival when compared to a placebo. These results underscore its effectiveness in improving treatment outcomes at earlier disease stages.
Insights from the ADRIATIC Clinical Trial
Patients receiving Durvalumab therapy experienced a notably extended overall survival compared to those given a placebo, with median survival times of 55.9 months versus 33.4 months.
Additionally, progression-free survival was considerably prolonged, with a median of 16.6 months for the Durvalumab group compared to 9.2 months for the placebo group.
The use of Durvalumab as an adjuvant treatment resulted in significantly improved overall survival and progression-free survival compared to placebo in patients with limited-stage small cell lung cancer.
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