Bristol Stock- Bristol Myers’ (BMY) Opdivo-Yervoy Combo Gets Positive CHMP Opinion
Bristol Myers Squibb Company BMY announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended approval of the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for another indication.
The combination has been recommended for approval for the treatment of adult patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) metastatic colorectal cancer (mCRC) after prior fluoropyrimidine-based combination chemotherapy.
The opinion was based on data from the phase II CheckMate -142 study, which demonstrated a durable clinical benefit in the Opdivo plus Yervoy cohort.
The recommendation will now be reviewed by the European Commission (EC).
The combination was approved in July 2018 for the treatment of adult and pediatric patients aged 12 years and older with MSI-H or dMMR mCRC that has progressed following treatment with fluoropyrimidine, oxaliplatin and irinotecan.
The combination was also approved in Japan by the Pharmaceuticals and Medical Devices Agency (PMDA) in September 2020 for the treatment of MSI-H unresectable, advanced or recurrent colorectal cancer progressing after cancer chemotherapy.
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, like metastatic melanoma, NSCLC, malignant pleural mesothelioma (MPM), and RCC, among others.
Opdivo-based therapies have now demonstrated positive results in phase III trials in earlier stages of four different types of cancer. Label expansion of the drug will further boost sales.
Bristol-Myers’ shares have gained 9.3% year to date against the industry’s decline of 4.4%.
The company’s performance in the first quarter of 2021 was dismal as Opdivo sales declined. Moreover, Revlimid sales weren’t impressive either.
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 Corp. 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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