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Bristol Myers (BMY) Gets FDA Nod for Another Opdivo Indication

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Bristol Myers Squibb BMY announced that the FDA has approved another label expansion of its blockbuster immuno-oncology drug, Opdivo (nivolumab).

Opdivo (injection for intravenous use) has been approved for the adjuvant treatment of completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT).

The approval was based on encouraging results from the phase III CheckMate -577 study that evaluated Opdivo (n=532) compared to placebo (n=262) in esophageal or GEJ cancer patients with residual pathologic disease following neoadjuvant CRT and complete resection.

Opdivo doubled median disease-free survival versus placebo for these patients in the phase III CheckMate -577study.

Esophageal and GEJ cancer patients with residual pathologic disease following neoadjuvant CRT and complete resection face a high risk of disease recurrence. Results of the CheckMate -577 study showed a doubling in median disease-free survival compared to placebo, which suggests that Opdivo could become a new standard of care for these patients.

In April, the FDA approved Opdivo in combination with fluoropyrimidine- and platinum-containing chemotherapy for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer and esophageal adenocarcinoma, regardless of PD-L1 expression status.

Opdivo is approved in several countries for various indications — unresectable or metastatic melanoma, metastatic non-small-cell lung carcinoma (NSCLC) with progression on or after platinum-based chemotherapy, metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy, advanced renal cell carcinoma (RCC), adult patients with classical Hodgkin lymphoma (cHL), and recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN), among others. It is also approved for various indications in combination with Yervoy.

Opdivo-based therapies have now demonstrated positive results in phase III trials in earlier stages of four different types of cancer — NSCLC, esophageal/gastroesophageal junction cancer, bladder cancer and melanoma. Label expansion of the drug will further boost sales.

Bristol-Myers’ shares have gained 9.6% year to date against the industry's decline of 6.2%.

The company’s performance in the first quarter of 2021 was dismal as Opdivo sales declined. Moreover, Revlimid sales weren’t impressive either.

We note that competition is stiff in the immune-oncology space from the likes of Merck’s MRK Keytruda and Roche’s RHHBY Tecentriq in key indications.

Nevertheless, the approval of new drugs adds a new stream of revenues, which should propel growth in the coming quarters.

Bristol-Myers currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Repligen Corporation RGEN, which carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Repligen’s earnings estimates for 2021 have increased to $2.21 from $1.91 in the past 60 days.

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