FDA APPROVALS

FDA granted accelerated approval to retifanlimab-dlwr (Zynyz, Incyte Corporation) for adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).  Read More.  View full prescribing information for Zynyz.

Food and Drug Administration approved dabrafenib (Tafinlar, Novartis) with trametinib (Mekinist, Novartis) for pediatric patients 1 year of age and older with low-grade glioma (LGG) with a BRAF V600E mutation who require systemic therapy. The FDA also approved new oral formulations of both drugs suitable for patients who cannot swallow pills. This represents the first FDA approval of a systemic therapy for the first-line treatment of pediatric patients with LGG with a BRAF V600E mutation. View full prescribing information for Tafinlar and Mekinist.  Read More. 

Food and Drug Administration (FDA) approved abemaciclib (Verzenio, Eli Lilly and Company) with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence. Read More.

Food and Drug Administration (FDA) approved dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) 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. Read More. 

Food and Drug Administration (FDA) approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.) for 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.  Read More. 

View full prescribing information for Trodelvy.

Lilly USA, LLC is pleased to announce that the US Food and Drug Administration (FDA) has approved Jaypirca™ (pirtobrutinib), 50 mg and 100 mg tablets, on January 27, 2023, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) after at least 2 lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. 

This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. For additional information, please see the press release here.

Please click for Prescribing Information and Patient Information for Jaypirca.

FDA announce a new approval of TUKYSA® (tucatinib, Seagen Inc.) tablets, for oral use in combination with trastuzumab for the treatment of adult patients with RAS wild-type, HER2-positive unresectable or metastatic colorectal cancer that has progressed following treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. Access the Full Prescribing Information for TUKYSA. Read More.

FDA) approved zanubrutinib (Brukinsa, BeiGene USA, Inc.) for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Read More. 

View full prescribing information for Brukinsa.

FDA approval of LUNSUMIO™ (mosunetuzumab-axgb) the first-in-class follicular lymphoma (FL) T-cell engaging bispecific antibody. LUNSUMIO, as a single agent, is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). Read More. 

Please see the LUNSUMIO full Prescribing Information for additional Important Safety Information, including BOXED Warning.

The FDA approved updated labeling for capecitabine tablets (Xeloda, Genentech, Inc.) under Project Renewal, an Oncology Center of Excellence (OCE) initiative aimed at updating labeling information for certain older oncology drugs to ensure information is clinically meaningful and scientifically up to date. This is the first drug to receive a labeling update under this pilot program. Read More.

Project Renewal is a collaborative program that leverages external oncology experts and early-career scientists to review existing published literature and gain first-hand experience in the selection, curation, and evaluation of evidence for independent FDA review. Project Renewal is intended to keep older, commonly prescribed oncology drugs’ labeling up to date, while providing transparency on FDA’s deliberative evaluation process and evidentiary standards, and improving awareness of drug labeling as an information resource for healthcare providers.