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AstraZeneca (AZN) Dato-DXd Breast Cancer BLA Gets FDA Acceptance

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AstraZeneca (AZN - Free Report) and partner Daiichi Sankyo announced that the FDA has accepted their biologics license application (BLA) seeking approval of the antibody drug conjugate, datopotamab deruxtecan (Dato-DXd), for a breast cancer indication.

The BLA is seeking approval of Dato-DXd for treating unresectable or metastatic HR+ HER2- breast cancer in patients who have received prior systemic therapy for unresectable or metastatic disease.

The FDA is expected to give its decision on the BLA in the first quarter of 2025 as the application has been granted a standard review.

The application was based on data from the TROPION-Breast01 phase III study. Data from the study demonstrated that treatment with Dato-DXd led to a statistically significant and clinically meaningful improvement for the dual primary endpoint of progression-free survival (PFS) compared to chemotherapy. For the dual primary endpoint of overall survival (OS), a trend of improvement was observed for Dato-DXd versus chemotherapy, though OS data were not mature at the time of data cut-off. The study will continue to assess OS.

If approved by the FDA, Dato-DXd can provide an alternative treatment option to conventional chemotherapy earlier in the metastatic setting.

In the past year, AstraZeneca’s stock has declined 3.8% against the industry’s 25.8% rise.

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Dato-DXd is being jointly developed by AstraZeneca and Daiichi Sankyo. AstraZeneca/Daiichi Sankyo are also seeking approval of Dato-DXd for advanced nonsquamous non-small cell lung cancer (NSCLC). A BLA for the NSCLC indication is under review with the FDA. The BLA is based on data from the pivotal TROPION-Lung01 phase III study. The FDA is expected to give its decision on the NSCLC BLA in the fourth quarter of 2024. Regulatory applications for Dato-DXd in lung and breast cancer are underway in several other countries, including the EU, China and Japan.

Antibody-drug conjugates or ADCs like Dato-DXd are being considered a disruptive innovation in the pharmaceutical industry as these will enable better treatment of cancer by harnessing the targeting power of antibodies to deliver cytotoxic molecule drugs to tumors.

Zacks Rank and Stocks to Consider

Currently, AstraZeneca has a Zacks Rank #3 (Hold).

Some better-ranked stocks in the healthcare sector are Vanda Pharmaceuticals (VNDA - Free Report) , ADMA Biologics (ADMA - Free Report) and MorphoSys (MOR - Free Report) , sporting a Zacks Rank #1 (Strong Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, 2024 estimates for Vanda Pharmaceuticals have improved from a loss of 46 cents to earnings of 1 cent. For 2025, loss estimates have narrowed from 94 cents to 48 cents per share in the past 60 days. In the past year, shares of VNDA have declined 39.8%.

Vanda Pharmaceuticals delivered a three-quarter average earnings surprise of 92.88%.

In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have improved from 22 cents to 30 cents. Estimates for 2025 have increased from 32 cents to 50 cents. In the past year, shares of ADMA Biologics have risen 97.0%.

Earnings of ADMA Biologics beat estimates in three of the last four quarters while meeting the same once. ADMA delivered a four-quarter average earnings surprise of 85.0%.

In the past 60 days, estimates for MorphoSys’ 2024 loss per share have narrowed from $2.26 to $2.08. Estimates for 2025 have narrowed from a loss of $1.09 per share to a loss of 89 cents per share. In the past year, shares of MOR have risen 358.5%.

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