Bristol Myers Squibb
BMY
announced that the FDA has approved the label expansion of its immuno-oncology drug Opdivo (nivolumab).
The regulatory body approved Opdivo 360 mg (injection for intravenous use) in combination with platinum-doublet chemotherapy every three weeks for three cycles for adult patients with resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC) in the neoadjuvant setting.
The approval is based on positive results from the phase III study CheckMate -816 wherein Opdivo plus platinum-doublet chemotherapy significantly improved event-free survival and pathologic complete response compared to platinum-doublet chemotherapy alone.
As a result, Opdivo-based combinations are now approved for both metastatic and earlier stages of non-small cell lung cancer.
This application was approved under the FDA’s Real-Time Oncology Review (RTOR) pilot program.
Shares of Bristol Myers have rallied 11.2% year to date against the
industry
’s decline of 18.3%.
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Opdivo is one of the top revenue generators for BMY and the label expansion of the drug for additional indications will boost the drug’s growth potential. The performance of immuno-oncology drug Opdivo, approved for multiple cancer indications, revived after a slowdown. Opdivo sales came in at $7.5 billion during 2021, up 8% from the 2020 figure.
Growth was primarily attributable to demand for metastatic indications, including first-line lung, first-line renal and first-line gastric cancers, as well as adjuvant indications with the approvals of adjuvant esophageal and adjuvant bladder cancers. BMY expects a strong performance from Opdivo in 2022 as well on sustained label expansions.
Last month, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended an approval of Opdivo in combination with fluoropyrimidine- and platinum-based chemotherapy for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) with PD-L1 expression ≥ 1%. The CHMP also recommended an approval of Opdivo plus Yervoy (ipilimumab) for the first-line treatment of adults with unresectable advanced, recurrent or metastatic ESCC with tumor cell PD-L1 expression ≥ 1%.
Key drugs, namely Revlimid and Eliquis also maintain a momentum for Bristol Myers. The approval of new drugs adds a revenue stream, which should boost growth in the coming quarters. The pipeline progress is steadily impressive and strategic collaborations will further expand the portfolio.
However, competition is stiff for Opdivo from the likes of
Merck
’s
MRK
Keytruda. Keytruda, approved for various oncology indications, is the key driver for MRK.
The FDA recently approved Keytruda for the adjuvant treatment of patients with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy or after nephrectomy and resection of metastatic lesions. Further label expansion of the drug will boost Merck’s top line.
Bristol-Myers currently carries a Zacks Rank #3 (Hold). A few better-ranked stocks in the biotech sector are
Vertex Pharmaceuticals
VRTX
and
Kaleido Biosciences
KLDO
, both carrying a Zacks Rank #2 (Buy) at present. You can see
the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
.
The consensus estimate for Vertex’s 2022 earnings has increased $1.20 over the past 60 days to $14.52. Shares of VRTX have gained 14.1% in the past year.
Loss estimates for KLDO have narrowed to $1.89 from $2.13 for 2022 in the past 60 days. Earnings of Kaleido Biosciences surpassed estimates in three of the trailing four quarters and missed the same on the remaining occasion.
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