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Bristol Myers (BMY) Receives FDA Approval for NSCLC Drug
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Bristol Myers Squibb (BMY - Free Report) announced that the FDA has approved repotrectinib, a TKI targeting ROS1 oncogenic fusions for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (“NSCLC”).
The candidate has been approved as an oral therapy under the brand name Augtyro.
The approval is based on positive results from the open-label, single-arm phase I/II study TRIDENT-1, which evaluated Augtyro in TKI-naïve and TKI-pretreated patients.
The primary endpoint of objective response rate (“ORR”), defined as the percentage of people treated within a certain period of time whose tumor size decreased (partial response) or who no longer have signs of cancer (complete response), was 79%. The median duration of response (mDOR) was 34.1 months. The ORR was 38% among patients pretreated with one prior ROS1 TKI and no prior chemotherapy and the mDOR was 14.8 months.
The candidate was added to BMY’s portfolio with the acquisition of Turning Point Therapeutics in August 2022. The approval will add Augtyro to Bristol Myers’ growing and differentiated NSCLC portfolio, expanding the company’s presence in precision medicine.
Bristol Myers is currently in transition mode as it shifts its mature product portfolio, which is facing generic competition, to new drugs.
Shares of the company have lost 28.3% year-to-date compared with the industry's decline of 22.5%.
Image Source: Zacks Investment Research
The approval of additional new drugs and the label expansion of existing ones will enable Bristol Myers to diversify its product base and offset the slowdown in top-line growth as Revlimid and Eliquis face generic competition.
The approval of drugs like Opdualag, Reblozyl, Breyanzi and Sotyktu has already added a new stream of revenues to BMY’s top line.
Bristol Myers’ immuno-oncology drug Opdivo is already approved for NSCLC.
We remind investors that the lucrative NSCLC market is pretty crowded with top players like Merck’s (MRK - Free Report) Keytruda, among others.
NSCLC accounts for 85% of lung cancer diagnoses, which is the leading cause of cancer deaths in the United States. The two main types of lung cancer are non-small cell and small cell.
Last month, Merck obtained FDA’s approval for Keytruda for the treatment of patients with resectable NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery. With this approval, Keytruda has six indications in NSCLC across both metastatic and earlier stages of NSCLC.
Dynavax’s loss per share estimates for 2023 have narrowed from 23 cents to 12 cents for 2023 in the past 30 days. During the same period, earnings estimates for 2024 rose from 3 cents to 18 cents. Shares of DVAX have gained 27.2% year to date.
Earnings estimates for Ligand Pharmaceuticals’ 2023 earnings per share have increased from $4.98 to $5.10 in the past 60 days. During the same period, earnings estimates for 2024 rose from $4.26 to $4.59.
Ligand beat earnings estimates in each of the last four quarters. The company has delivered an earnings surprise of 67.19%, on average.
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Bristol Myers (BMY) Receives FDA Approval for NSCLC Drug
Bristol Myers Squibb (BMY - Free Report) announced that the FDA has approved repotrectinib, a TKI targeting ROS1 oncogenic fusions for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (“NSCLC”).
The candidate has been approved as an oral therapy under the brand name Augtyro.
The approval is based on positive results from the open-label, single-arm phase I/II study TRIDENT-1, which evaluated Augtyro in TKI-naïve and TKI-pretreated patients.
The primary endpoint of objective response rate (“ORR”), defined as the percentage of people treated within a certain period of time whose tumor size decreased (partial response) or who no longer have signs of cancer (complete response), was 79%. The median duration of response (mDOR) was 34.1 months. The ORR was 38% among patients pretreated with one prior ROS1 TKI and no prior chemotherapy and the mDOR was 14.8 months.
The candidate was added to BMY’s portfolio with the acquisition of Turning Point Therapeutics in August 2022. The approval will add Augtyro to Bristol Myers’ growing and differentiated NSCLC portfolio, expanding the company’s presence in precision medicine.
Bristol Myers is currently in transition mode as it shifts its mature product portfolio, which is facing generic competition, to new drugs.
Shares of the company have lost 28.3% year-to-date compared with the industry's decline of 22.5%.
Image Source: Zacks Investment Research
The approval of additional new drugs and the label expansion of existing ones will enable Bristol Myers to diversify its product base and offset the slowdown in top-line growth as Revlimid and Eliquis face generic competition.
The approval of drugs like Opdualag, Reblozyl, Breyanzi and Sotyktu has already added a new stream of revenues to BMY’s top line.
Bristol Myers’ immuno-oncology drug Opdivo is already approved for NSCLC.
We remind investors that the lucrative NSCLC market is pretty crowded with top players like Merck’s (MRK - Free Report) Keytruda, among others.
NSCLC accounts for 85% of lung cancer diagnoses, which is the leading cause of cancer deaths in the United States. The two main types of lung cancer are non-small cell and small cell.
Last month, Merck obtained FDA’s approval for Keytruda for the treatment of patients with resectable NSCLC in combination with platinum-containing chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery. With this approval, Keytruda has six indications in NSCLC across both metastatic and earlier stages of NSCLC.
Zacks Rank and Other Stocks to Consider
BMY currently has a Zacks Rank #3 (Hold).
A couple of other top-ranked stocks in the overall healthcare sector are Dynavax Technologies (DVAX - Free Report) and Ligand Pharmaceuticals , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Dynavax’s loss per share estimates for 2023 have narrowed from 23 cents to 12 cents for 2023 in the past 30 days. During the same period, earnings estimates for 2024 rose from 3 cents to 18 cents. Shares of DVAX have gained 27.2% year to date.
Earnings estimates for Ligand Pharmaceuticals’ 2023 earnings per share have increased from $4.98 to $5.10 in the past 60 days. During the same period, earnings estimates for 2024 rose from $4.26 to $4.59.
Ligand beat earnings estimates in each of the last four quarters. The company has delivered an earnings surprise of 67.19%, on average.