Daily Newsletter

16 October 2023

Daily Newsletter

16 October 2023

US FDA grants approval for BMS’ Opdivo for melanoma

The approval is based on findings from the Phase III CheckMate-76K clinical trial of Opdivo.

Vishnu Priyan October 16 2023

The US Food and Drug Administration (FDA) has granted approval for Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) to treat stage IIB or IIC melanoma patients who have undergone complete resection.

Opdivo is indicated for usage as adjuvant therapy in adult and paediatric individuals aged 12 years and above.

The approval is based on findings from the Phase III CheckMate-76K clinical trial of Opdivo versus placebo.

Trial data showed that Opdivo offered a 58% decline in recurrence risk, in the occurrence of new primary melanoma and in mortality, compared to placebo.

The recurrence-free survival (RFS) rate was 89% for Opdivo and 79% for placebo at one year.

Bristol Myers Squibb US cardiovascular, immunology and oncology senior vice-president and general manager Catherine Owen stated: “This approval builds on our existing adjuvant indication in completely resected stage III or IV disease and now provides eligible patients with completely resected stage IIB or IIC melanoma an additional treatment option, which may help prevent recurrence.

“BMS remains committed to its goal of helping improve patient outcomes in melanoma and bringing immunotherapy to more patients, including in the earlier stages of the disease.”

The FDA has already Opdivo as an adjuvant treatment in patients aged 12 years and above with melanoma that involves lymph nodes or metastatic disease following surgical resection.

In August 2023, the company received approval from the European Commission for Opdivo as an adjuvant treatment for the same indication.

Significant unmet need in the Diabetic nephropathy (DN) market

With only a few approved drugs currently available to treat DN by means other than regulation of blood pressure, innovator products that can treat by targeting other factors such as treatment of dyslipidemia, hypertension, or angiotensin inhibition, among others, is a key area of R&D in the DN space and is likely to pave the way for novel therapies in the near future. However, the treatment landscape is expected to remain unchanged due to limited availability of products in the late-stage pipeline currently.

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