The US FDA New Drug Approvals in June 2025

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of June 2025 The US FDA has approved a total of 5 new drugs, including 2 new molecular entities and 3 biologics, leading to the treatment of patients and advances in the pharmaceutical industry The major highlighted drug was Daiichi Sankyo and AstraZeneca’s Datroway, securing…

ByDipanshu DixitJuly 15, 2025

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Daiichi Sankyo and AstraZeneca Report the US FDA Approval of Datroway for Advanced EGFR-Mutated NSCLC

Shots:The US FDA has approved Datroway (datopotamab deruxtecan-dlnk; 6 mg/kg) for adults with locally advanced or metastatic EGFR-mutated NSCLC previously treated with EGFR therapy & Pt CTApproval was based on the global P-II (TROPION-Lung05) trial results (n=137) and supported by data from the P-III (TROPION-Lung01) trial (n=590), which showed a 45% confirmed ORR…

ByDipanshu DixitJune 26, 2025

News

AstraZeneca and Daiichi Sankyo Receive the EC’s Approval for Datroway to Treat HR+/HER2- Breast Cancer

Shots:The EC has approved Datroway to treat unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer in pts who have received endocrine therapy & ≥1L of CT in the advanced settingApproval was based on global P-III (TROPION Breast01) trial, assessing Datroway (6mg/kg; IV, Q21D) vs single agent CT (eribulin,…

ByDipanshu DixitApril 10, 2025

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AstraZeneca to Highlight Tagrisso’s Clinical Data for NSCLC at ELCC 2025

Shots:AstraZeneca to present Tagrisso’s data from P-III (LAURA & FLAURA2) & P-II (SAVANNAH & ORCHARD) trials at ELCC 2025 for EGFRm NSCLC pts who failed or received 1L therapy; data to support global filingsIn LAURA, Tagrisso showed favorable OS trend (mOS: 58.8 vs 54.1mos.; maturity: 31%) despite 78% of PBO pts receiving it…

ByRidhi RastogiMarch 25, 2025

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The US FDA New Drug Approvals in January 2025

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of January 2025 The US FDA has approved a total of 3 new drug including 2 new molecular entities and 1 biologic leading to the treatment of patients and advances in the healthcare industry The major highlighted drug was Daiichi Sankyo &…

ByDipanshu DixitFebruary 11, 2025

News

AstraZeneca and Daiichi Sankyo Receive CHMP’s Positive Opinion for Datroway to Treat HR+/HER2- Breast Cancer

Shots:The CHMP has recommended Datroway to treat unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer in pts receiving endocrine-based therapy & CT. Ongoing regulatory review in China & other regions Opinion was supported by a global P-III (TROPION Breast01) trial, assessing Datroway (6mg/kg; IV, Q21D) vs single agent…

ByDipanshu DixitFebruary 3, 2025

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Daiichi Sankyo and AstraZeneca Dose the First Patient with Adjuvant Datroway in P-III (TROPION-Lung12) Trial for Adenocarcinoma NSCLC

Shots:Daiichi & AstraZeneca have dosed first patient with adj. Datroway (6 mg/kg) + rilvegostomig/ rilvegostomig monotx. (750mg) in P-III (TROPION-Lung12) trial to treat stage 1a/1b adenocarcinoma NSCLC (tumors <4 cm) after complete tumor resection who are ctDNA+ or exhibit high-risk of relapse Study will evaluate DFS as the 1EP, while OS, safety, patient-reported…

ByDipanshu DixitJanuary 31, 2025

News

Daiichi Sankyo and AstraZeneca Receives the US FDA Approval for Datroway (Datopotamab Deruxtecan-dlnk) to Treat HR+/HER2- Metastatic Breast Cancer

Shots:The FDA has approved Datroway to treat unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer in patients receiving endocrine-based therapy & CT. Submissions are under review in the EU, China, & other areas Approval was based on a global P-III (TROPION Breast01) trial, assessing Datroway (6mg/kg; IV, Q21D)…

ByDipanshu DixitJanuary 20, 2025

The US FDA New Drug Approvals in June 2025

Daiichi Sankyo and AstraZeneca Report the US FDA Approval of Datroway for Advanced EGFR-Mutated NSCLC

AstraZeneca and Daiichi Sankyo Receive the EC’s Approval for Datroway to Treat HR+/HER2- Breast Cancer

AstraZeneca to Highlight Tagrisso’s Clinical Data for NSCLC at ELCC 2025

The US FDA New Drug Approvals in January 2025

AstraZeneca and Daiichi Sankyo Receive CHMP’s Positive Opinion for Datroway to Treat HR+/HER2- Breast Cancer

Daiichi Sankyo and AstraZeneca Dose the First Patient with Adjuvant Datroway in P-III (TROPION-Lung12) Trial for Adenocarcinoma NSCLC

Daiichi Sankyo and AstraZeneca Receives the US FDA Approval for Datroway (Datopotamab Deruxtecan-dlnk) to Treat HR+/HER2- Metastatic Breast Cancer

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