FDA expands label for AZ's Tagrisso in key NSCLC indication

FDA approves osimertinib for non-small cell lung cancer

On September 25, 2024, the FDA approved osimertinib (Tagrisso, AstraZeneca Pharmaceuticals) for adult patients with locally advanced, ...

The FDA has signed off on Tagrisso to become the first targeted therapy for unresectable, stage 3 EGFRm non-small cell lung cancer.

Tagrisso approved in the US for patients with unresectable, Stage III ...

Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous ...

AstraZeneca Expands Tagrisso's NSCLC Label, FDA Allows Use ...

Tagrisso's other non-small cell lung cancer (NSCLC) indications include first-line use in metastatic disease, its use as an adjuvant therapy ...

AZ gets sought-after lung cancer approval for Tagrisso

AstraZeneca's EGFR inhibitor Tagrisso has been approved by the FDA for a new lung cancer indication that could make it a go-to therapy for a patient population

ASCO: AZ's latest Tagrisso data receive standing ovation

Tagrisso delivered a 84% progression-free survival benefit in EGFR-mutated NSCLC, as Imfinzi cut the risk of death by 27% in LS-SCLC.

AZN's Tagrisso Gets FDA Nod for Expanded Use in NSCLC

The regulatory body has approved Tagrisso for the treatment of unresectable, stage III EGFR-mutated non-small cell lung cancer (NSCLC) in adult patients.

TAGRISSO® (osimertinib) tablets, for oral use - accessdata.fda.gov

TAGRISSO is indicated as adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth ...

AZ's Tagrisso plus chemo get fast FDA review for lung cancer

Rybrevant is currently approved only for a subcategory of EGFR+ NSCLC patients with exon 20 mutations – a niche indication not on Tagrisso's ...

Imfinzi approved in the US for the treatment of resectable non-small ...

AstraZeneca's Imfinzi (durvalumab) in combination with chemotherapy has been approved in the US for the treatment of adult patients with resectable early-stage ...

FDA Approves Osimertinib for Locally Advanced, Unresectable ...

The FDA approved osimertinib for EGFR-mutated, locally advanced, unresectable, non–small cell lung cancer after chemoradiation.

TAGRISSO® (osimertinib) tablets, for oral use - accessdata.fda.gov

TAGRISSO is indicated for the treatment of adult patients with metastatic EGFR T790M mutation- positive NSCLC, as detected by an FDA-approved test, whose ...

Treatment for Resectable and Metastatic EGFRm NSCLC ...

Learn about TAGRISSO® (osimertinib), a targeted therapy for resectable EGFRm non-small cell lung cancer (NSCLC) and the first-line treatment of metastatic ...

Syndax Wins First FDA Nod for Menin Blocker in Relapsed or ...

Under the expanded label, Imfinzi can be given with chemotherapy to NSCLC patients who have no known EGFR or ALK mutations. After surgery, Imfinzi can be given ...

Efficacy of TAGRISSO® (osimertinib) in Resectable EGFRm NSCLC

Osimertinib (TAGRISSO) is the first and only EGFR TKI recommended by NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as an adjuvant treatment ...

Clinical Review - Osimertinib (Tagrisso) - NCBI Bookshelf

The clinical panel indicated that patients without an EGFR mutation (e.g., those with interstitial lung disease or cardiac dysfunction) or with intolerable ...

FDA-approved novel therapeutic drugs for solid tumors from 1991 to ...

These drugs have extended indications for other malignancies, constituting a cancer treatment system for monotherapy or combined therapy. However, the available ...

208065Orig1s000 - accessdata.fda.gov

EGFR mutation positive NSCLC accounts for about 15% of lung cancer in the United. States, and 30 to 50% of lung cancer in Asia. EGFR mutations ...

AstraZeneca/Daiichi's ADC shows better survival for nonsquamous ...

Datopotamab deruxtecan treatment led to greater overall survival (OS) than docetaxel chemotherapy in a group of non-small cell lung cancer (NSCLC) patients.

208065Orig1s000 - accessdata.fda.gov

• Proposed Indication: Non-small cell lung cancer (NSCLC) ... FDA noted that the TAGRISSO label with FDA proposed edits will be sent to AZ this ...