FDA, Datroway and AstraZeneca

FDA Approves Metastatic Breast Cancer Drug, Datroway
The FDA has approved AstraZeneca and Daiichi Sankyo’s Datroway (datopotamab deruxtecan-dlnk) to treat unresectable or metastatic hormone receptor HR+, HER2- breast cancer in adult patients who have previously received endocrine-based therapy and chemotherapy for unresectable or metastatic disease, according to a news release.
FDA Approves AstraZeneca, Daiichi Sankyo’s Datroway for Previously Untreated Unresectable, Metastatic HR-Positive, HER2-Negative Breast Cancer
Approval is based on results from the TROPION-Breast01 Phase III trial, in which Datroway demonstrated a significant reduction in the risk of disease progression or death in patients with previously treated,
US FDA approves AstraZeneca's drug for breast cancer
The U.S. Food and Drug Administration has approved AstraZeneca and partner Daiichi Sankyo's precision drug to treat a type of breast cancer, the health regulator said on Friday.
Daiichi Sankyo Shares Jump After U.S. FDA Approves Breast Cancer Drug
Daiichi Sankyo shares rose sharply after the U.S. Food and Drug Administration approved its breast cancer drug Datroway. Shares were recently 8.7% higher at 4,437 yen, equivalent to $28.39, on Monday after rising as much as 9.7% earlier. Over the past three years, the stock posted a daily gain of more than 8% only four times.
AstraZeneca’s Datroway approved in U.S. for HER2-negative breast cancer patients
DXd, has been approved in the US for the treatment of adult patients with unresectable or metastatic hormone receptor HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.
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FDA approves MediBeacon’s TGFR system for kidney function assessment
The US Food and Drug Administration (FDA) has granted approval to the MediBeacon Transdermal GFR (TGFR) system for evaluating ...
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FDA Approves Amgen’s Lumakras Plus Vectibix for KRAS G12C-Mutated Metastatic Colorectal Cancer
Approval is based on data from the Phase III CodeBreaK 300 trial, which demonstrated that treatment with Lumakras and ...
Zyn nicotine pouches get FDA approval
FDA authorizes Zyn nicotine pouches, citing public health benefits for adult smokers, despite concerns over flavored products ...
GlobalData on MSN13h
FDA approves Amgen’s combo therapy for colorectal cancer
Amgen’s LUMAKRAS (sotorasib) and Vectibix (panitumumab) combination has received approval from the US Food and Drug ...
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FDA Approves Sotorasib + Panitumumab for mCRC
In the CodeBreaK 300 trial, sotorasib and panitumumab had better response rates and improved PFS vs standard-of-care ...
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Federal watchdog raises some concerns about the FDA’s accelerated approval program
The Office of Inspector General reviewed the FDA’s use of accelerated approval for 24 drugs, ultimately finding issues with ...
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Government watchdog recommends tweaks to FDA accelerated approval program
The FDA established its accelerated approval program in 1992 to allow drugs to reach the market quickly for life-threatening ...
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FDA Finalizes Guidance on Communication of Unapproved Uses of Approved or Cleared Medical Products
On January 6, 2025, the FDA released final guidance for industry entitled “Communications From Firms to Health Care Providers Regarding ...
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FDA approves Zydus’ Phase IIb trial of Usnoflast for ALS treatment
The FDA has granted approval for Zydus to proceed with the Phase II(b) trial of Usnoflast for amyotrophic lateral sclerosis (ALS) treatment.