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Bristol Myers Squibb Company (BMY - Free Report) 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.
We note that competition is stiff in the immune-oncology space from the likes of Merck’s (MRK - Free Report) Keytruda and Roche’s (RHHBY - Free Report) Tecentriq in key indications.
Nevertheless, the approval of new drugs adds a new stream of revenues, which should propel growth in the coming quarters.
Repligen’s earnings estimates for 2021 have increased to $2.21 from $1.91 in the past 60 days.
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Bristol Myers' (BMY) Opdivo-Yervoy Combo Gets Positive CHMP Opinion
Bristol Myers Squibb Company (BMY - Free Report) 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.
We note that competition is stiff in the immune-oncology space from the likes of Merck’s (MRK - Free Report) Keytruda and Roche’s (RHHBY - Free Report) 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 Corp. (RGEN - Free Report) , 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.
Infrastructure Stock Boom to Sweep America
A massive push to rebuild the crumbling U.S. infrastructure will soon be underway. It’s bipartisan, urgent, and inevitable. Trillions will be spent. Fortunes will be made.
The only question is “Will you get into the right stocks early when their growth potential is greatest?”
Zacks has released a Special Report to help you do just that, and today it’s free. Discover 7 special companies that look to gain the most from construction and repair to roads, bridges, and buildings, plus cargo hauling and energy transformation on an almost unimaginable scale.
Download FREE: How to Profit from Trillions on Spending for Infrastructure >>