AstraZeneca AZN and its Japanese partner Daiichi Sankyo announced that they have voluntarily withdrawn the marketing authorization application (MAA) for their antibody-drug conjugate (ADC), datopotamab deruxtecan (Dato-DXd).

The MAA sought approval of Dato-DXd for treating adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) based on the TROPION-Lung01 phase III study.

The companies decided to withdraw the MAA for Dato-DXd in nonsquamous NSCLC following feedback from the European Medicines Agency’s Committee for Medicinal Products for Human Use.

Last month, AZN and Daiichi Sankyo withdrew the biologics license application (BLA) seeking approval of Dato-DXd for the same indication in the United States and instead filed a new BLA for previously treated advanced EGFR-mutated NSCLC.

The BLA was based on data from the phase II TROPION-Lung05 study and supported by data from the phase III TROPION-Lung01 study.

Shares of AstraZeneca have decreased 1.6% in the past year against the industry’s increase of 4%.

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Recent Updates on AZN & Daiichi's Dato-DXd

Earlier this month, the FDA granted a Breakthrough Therapy designation to Dato-DXd for previously treated advanced EGFR-mutated NSCLC.

Besides lung 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.

A regulatory filing seeking approval of Dato-DXd for treating unresectable or metastatic HR+ HER2- breast cancer is also under review in the European Union.

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

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, which are 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 PFE’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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