AstraZeneca AZN and its Japanese partner Daiichi Sankyo announced that the FDA has granted a Breakthrough Therapy designation (BTD) to their antibody-drug conjugate (ADC), datopotamab deruxtecan (Dato-DXd), for a lung cancer indication.

The regulatory granted the BTD to Dato-DXd for the treatment of locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) in adult patients whose disease progressed on or after treatment with an EGFR-tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy.

The FDA grants BTD to expedite the development and review of therapies for severe or life-threatening diseases where preliminary clinical evidence shows that the therapy may provide substantial improvements over available treatments.

Dato-DXd is being jointly developed by AstraZeneca and Daiichi Sankyo. This marks the first BTD for Dato-DXd for any indication.

Year to date, shares of AstraZeneca have inched up 1.8% compared with the industry’s rise of 9.5%.

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BTD for Dato-DXd Based on AZN’s TROPION-Lung05 Study

The FDA’s BTD for Dato-DXd was based on data from the phase II TROPION-Lung05 study and supported by data from the phase III TROPION-Lung01 study.

Based on the same data, last month, AstraZeneca and Daiichi Sankyo submitted a new biologics license application (BLA) seeking accelerated approval of Dato-DXd for previously treated advanced EGFR-mutated NSCLC.

The companies also voluntarily withdrew their earlier BLA seeking approval of Dato-DXd for the broader advanced or metastatic nonsquamous NSCLC based on data from the phase III TROPION-Lung01 study.

The decision to withdraw the BLA for nonsquamous NSCLC and instead submit one for EGFR-mutated NSCLC was based on feedback from the FDA.

AZN & Daiichi's Dato-DXd for Breast Cancer

AstraZeneca and Daiichi Sankyo are also seeking approval of Dato-DXd for unresectable or metastatic HR+ HER2- breast cancer. A BLA for this breast cancer indication is currently under review in the United States based on data from the TROPION-Breast01 phase III study. A decision from the FDA is expected in the first quarter of 2025.

AstraZeneca and Daiichi have separate studies ongoing for Dato-DXd for triple-negative or HR-low, HER2-negative breast cancers.

Regulatory applications for Dato-DXd in lung and breast cancer are underway in several other countries, including the EU, China and Japan.

Other Companies Making ADC Drugs

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

Daiichi Sankyo has six ADCs in clinical development across multiple types of cancers, being developed utilizing its DXd ADC technology. In addition to Dato-DXd, Daiichi markets Enhertu, a HER2-directed ADC for HER2-mutated breast, lung and gastric cancers, in partnership with AstraZeneca.

Daiichi and Merck MRK are co-developing and co-commercializing three ADCs — patritumab deruxtecan/MK-1022, raludotatug deruxtecan/MK-5909 and ifinatamab deruxtecan/MK-2400.

While raludotatug deruxtecan is being developed in phase II/III study for ovarian cancer, ifinatamab deruxtecan is being studied for small-cell lung cancer in phase III and colorectal, bladder, endometrial and head and neck cancers in phase II.

The FDA has issued a complete response letter to Merck/Daiichi’s BLA seeking accelerated approval for patritumab deruxtecan in previously treated EGFR-mutated NSCLC.

Pfizer PFE also has a strong portfolio of ADC drugs, which were added with the acquisition of cancer biotech, Seagen. The December 2023 acquisition of Seagen added four ADCs — Adcetris, Padcev, Tukysa and Tivdak — to Pfizer’s portfolio.

Adcetris, Padcev, Tukysa and Tivdak contributed $268 million, $409 million, $124 million and $34 million, respectively, to Pfizer’s oncology revenues in the third quarter.

AZN's Zacks Rank

AstraZeneca currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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