FDA Approves Polatuzumab Vedotin-piiq for Previously Untreated Diffuse Large B-cell Lymphoma

On April 19, the U.S Food and Drug Administration (FDA) approved polatuzumab vedotin-piiq with a rituximab product, cyclophosphamide, doxorubicin, and prednisone for adult patients who have previously untreated diffuse large B-cell lymphoma, not otherwise specified, or high-grade B-cell lymphoma and who have an International Prognostic Index score of 2 or greater.

For more information, read the FDA announcement and Genentech announcement

Posted 4/21/2023

FDA Approves Enfortumab Vedotin-ejfv + Pembrolizumab for Locally Advanced or Metastatic Urothelial Carcinoma

On April 3, U.S the Food and Drug Administration (FDA) granted accelerated approval to enfortumab vedotin-ejfv with pembrolizumab for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.

For more information read the FDA announcement, the Merck announcement and the Seagen announcement. 

Posted 4/3/2023

FDA Grants Accelerated Approval to Retifanlimab-dlwr for MCC

On March 22, 2023, the U.S Food and Drug Administration granted accelerated approval to retifanlimab-dlwr for adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).

For more information read the FDA announcement and the Incyte announcement. 

Posted 3/22/2023

FDA Approves Dabrafenib + trametinib for Pediatric Patients with LGG

On March 16, 2023, the U.S Food and Drug Administration (FDA) approved dabrafenib with trametinib for pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy.

For more information read the FDA announcement and the Novartis announcement.

Posted 3/20/2023

FDA Approves Pegfilgrastim-cbqv

On March 6, 2023 the U.S Food and Drug Administration (FDA) approved a single-dose, prefilled autoinjector presentation of pegfilgrastim-cbqv, a biosimilar pegfilgrastim administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia. 

For more information read the Coherus Biosciences announcement. 

Posted 3/8/2023

FDA Expands Early Breast Cancer Indication for Abemaciclib with Endocrine Therapy

On March 3, 2023, the U.S Food and Drug Administration (FDA) approved an expanded indication for abemaciclib, in combination with endocrine therapy, for the adjuvant treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer at a high risk of recurrence. 

For more information read the FDA announcement and the Lilly Oncology announcement. 

Posted 3/6/2023

FDA Approves Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma

On January 27, 2023, the U.S Food and Drug Administration (FDA) granted accelerated approval to pirtobrutinib for the treatment of adult patients with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton's tyrosine kinase inhibitor.

For more information, read the FDA announcement and the Lilly Oncology announcement.

Posted 3/3/2023

FDA Approves Trodelvy® in Pre-treated HR+/HER2- Metastatic Breast Cancer

On February 3, 2023, the U.S. Food and Drug Administration (FDA) approved Trodelvy^® (sacituzumab govitecan-hziy) for the treatment of adult patients with unresectable locally advanced 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 endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.

Click here to review the data.

Please see full Prescribing Information including BOXED WARNING.

TRODELVY, the TRODELVY logo, GILEAD, and the GILEAD logo are trademarks of Gilead Sciences, Inc., or its related companies.

©2023 Gilead Sciences, Inc. All rights reserved. US-TROP-0782 02/23

FDA Approves Dostarlimab-gxly for dMMR Endometrial Cancer

On February 9, 2023, the U.S Food and Drug Administration (FDA) approved dostarlimab-gxly for adult patients with mismatch repair deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.

For more information, read the FDA announcement, and the GlaxoSmithKline announcement. 

Posted 2/10/2023

FDA Approves Pembrolizumab as Adjuvant Treatment for NSCLC

On January 26, 2023, the U.S Food and Drug Administration (FDA) approved pembrolizumab for adjuvant treatment following resection and platinum-based chemotherapy for stage IB (T2a ≥4 cm), II, or IIIA non-small cell lung cancer (NSCLC).

For more information read the FDA announcement and the Merck announcement. 

Posted 1/27/2023