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AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved a new treatment regimen for CALQUENCE® (acalabrutinib) in combination with venetoclax for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Approval was based on results from the randomized, multicenter, open-label phase III AMPLIFY trial. AMPLIFY 3.5-Year Data […]

AstraZeneca announced that ENHERTU® (fam-trastuzumab deruxtecan-nxki), in combination with pertuzumab, is now FDA-approved as a first-line treatment for adult patients with unresectable or metastatic HER2-positive (IHC 3+ or ISH+) breast cancer as determined by an FDA-approved test. ENHERTU has Boxed WARNINGS for interstitial lung disease (ILD)/pneumonitis and embryo-fetal toxicity.

US approval of AstraZeneca’s IMFINZI® (durvalumab) in combination with standard-of-care FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) for the treatment of adult patients with resectable, early-stage and locally advanced (Stages II, III, IVA) gastric and gastroesophageal junction (GEJ) cancers. The approved regimen includes neoadjuvant IMFINZI in combination with chemotherapy before surgery, followed by adjuvant IMFINZI in […]

ENHERTU® (fam-trastuzumab deruxtecan-nxki) is now approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-low (IHC 1+ or IHC 2+/ISH-) or HER2-ultralow (IHC 0 with membrane staining) breast cancer, as determined by an FDA-approved test, that has progressed on one or more endocrine therapies in the metastatic setting. The approval […]

Pfizer announces that on February 11, 2025, the FDA approved the 8th indication for ADCETRIS® (brentuximab vedotin) in adult patients with relapsed or refractory large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) NOS, DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy who are not […]

The US Food and Drug Administration (FDA) has approved a new indication for CALQUENCE® (acalabrutinib) in combination with bendamustine and rituximab (BR) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). Approval was based on results from the Phase III, randomized, […]

On January 17, 2025, the US Food and Drug Administration (FDA) approved DATROWAY® (datopotamab deruxtecan-dlnk) for the treatment of adult patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received prior endocrine-based therapy and chemotherapy for unresectable or […]

AstraZeneca recently announced that the US Food and Drug Administration (FDA) had approved a new indication for IMFINZI® (durvalumab) for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT). Approval was based on results from the Phase III, global, double-blind, placebo-controlled ADRIATIC trial. […]

On September 25, 2024, TAGRISSO® (osimertinib) was approved for the treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. For your reference, attached […]

Imfinzi (durvalumab) in combination with carboplatin and paclitaxel followed by Imfinzi monotherapy has been approved in the US for adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR).1 Additional information on the approval can be found in the press release below. https://www.astrazeneca.com/media-centre/press-releases/2024/imfinzi-approved-in-the-us-for-endometrial-cancer.html