The European Commission has granted approval to Bristol Myers Squibb for Opdivo (nivolumab) plus platinum-based chemotherapy to treat resectable non-small cell lung cancer (NSCLC) patients.
The neoadjuvant treatment is indicated for adult individuals with NSCLC with tumour cell PD-L1 expression greater than or equal to 1%, who are at increased risk of recurrence.
Opdivo with chemotherapy is the first therapy option of its kind to receive approval for use in neoadjuvant settings in such patients in the European Union (EU).
The regulatory agency granted approval based on the Phase III CheckMate -816 clinical trial finding.
Three cycles of the combination treatment were found to offer improvement in event-free survival and pathologic complete response versus chemotherapy alone.
The safety profile of Opdivo plus chemotherapy was noted to be in line with those observed earlier.
Opdivo-based regimens have previously received approval for usage in treating early stages of melanoma, oesophagal/gastroesophageal junction cancer and urothelial carcinoma in the region.
Bristol Myers Squibb thoracic cancers global programme lead vice-president Abderrahim Oukessou stated: “Opdivo in combination with chemotherapy is now the first and only approved immunotherapy-based neoadjuvant treatment option for non-small cell lung cancer in the EU, and we look forward to offering certain patients in Europe a solution that may help reduce their risk of disease recurrence, progression and death.”
In March 2022, the company received approval for the Opdivo combination therapy from the US Food and Drug Administration to treat adult resectable NSCLC patients.
Source link
#BMS #receives #approval #Opdivo #regimen #lung #cancer
