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Drugs

A carefully crafted resource to ensure that oncology professionals stay up-to-date with the most recent drug updates and FDA approvals. Here, you'll discover a collection of vital information, enabling you to make well-informed choices and provide advanced care to your patients. Keep up with the ever-changing world of oncology treatments with our extensive updates, guaranteeing that your practice stays at the forefront.

Latest Drug Updates

  • August 04, 2023 11:32 AM | Katy Monaco (Administrator)

    Food and Drug Administration approved dostarlimab-gxly (Jemperli, GlaxoSmithKline) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for primary advanced or recurrent endometrial cancer (EC) that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H).  Read More. 

    View full prescribing information for Jemperli.

  • August 01, 2023 11:31 AM | Katy Monaco (Administrator)

    Food and Drug Administration approved quizartinib (Vanflyta, Daiichi Sankyo, Inc.) with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive, as detected by an FDA-approved test. FDA also approved LeukoStrat CDx FLT3 Mutation Assay as a companion diagnostic for Vanflyta. Read More

    View full prescribing information for Vanflyta.

  • June 23, 2023 11:48 AM | Katy Monaco (Administrator)

    FDA has approved TALZENNA (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, in combination with XTANDI (enzalutamide), for the treatment of adult patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC). This approval is based on the statistically significant and clinically meaningful radiographic progression-free survival (rPFS) data from the Phase 3 TALAPRO-2 trial, which demonstrated a 55% reduction in the risk of disease progression or death in patients with mCRPC with prospectively identified HRR gene mutations (ATM, ATR, BRCA1, BRCA2, CDK12, CHEK2, FANCA, MLH1, MRE11A, NBN, PALB2, or RAD51C) treated with TALZENNA plus XTANDI vs placebo plus XTANDI (HR 0.45; 95% CI, 0.33–0.61; p<0.0001).  Read More

  • June 19, 2023 11:47 AM | Katy Monaco (Administrator)

    FDA has approved Columvi® (glofitamab-gxbm) for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response in the Phase I/II NP30179 study. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.  Read More

  • June 02, 2023 1:51 PM | Katy Monaco (Administrator)

    AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been approved in the US for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC). Read more.

  • May 23, 2023 12:44 PM | Katy Monaco (Administrator)

    FDA has approved AYVAKIT® (avapritinib) for the treatment of adults with indolent systemic mastocytosis (ISM). All U.S. patients with ISM now have access to the first and only approved medicine designed to treat their disease. AYVAKIT (avapritinib) is a precision therapy approved by the FDA for the treatment of three indications: adults with ISM, adults with advanced systemic mastocytosis, including aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN) and mast cell leukemia (MCL), and adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations. For more information, visit AYVAKIT.com.  Read more.

    View full prescribing information here.

  • May 19, 2023 12:53 PM | Katy Monaco (Administrator)

    Genmab A/S announced that the U.S. Food and Drug Administration (FDA) has approved EPKINLY™ (epcoritamab-bysp) as the first and only T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS), including DLBCL arising from indolent lymphoma, and high-grade B‑cell lymphoma, after two or more lines of systemic therapy. EPKINLY was approved under accelerated approval based on response rate and durability of response. Continued approval for this indication is contingent upon verification and description of clinical benefit in a confirmatory trial(s). EPKINLY is being co-developed and co-commercialized by Genmab and AbbVie as part of the companies’ oncology collaboration. Read More

    Please see the full Prescribing Information and Medication Guide, including Boxed Warnings.

  • April 28, 2023 12:48 PM | Katy Monaco (Administrator)

    Food and Drug Administration (FDA) approved elacestrant (Orserdu, Stemline Therapeutics, Inc.) for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. FDA also approved the Guardant360 CDx assay as a companion diagnostic device to identify patients with breast cancer for treatment with elacestrant. Read more. View full prescribing information for Orserdu.

  • April 24, 2023 12:57 PM | Katy Monaco (Administrator)

    The Menarini Group (“Menarini”), a leading Italian pharmaceutical and diagnostics company, announced that the U.S. Food and Drug Administration (FDA) has approved ORSERDU (elacestrant). Stemline Therapeutics (“Stemline”), a wholly-owned subsidiary of the Menarini Group, headquartered in New York and focused on bringing transformational oncology treatments for cancer patients, will commercialize ORSERDU in the U.S.

    Click here for more information.

    Click here for full prescribing information.

  • April 21, 2023 2:33 PM | Katy Monaco (Administrator)

    FDA has approved Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL) and who have an International Prognostic Index (IPI) score of two or greater. This FDA decision converts the accelerated approval of Polivy in combination with bendamustine and Rituxan for relapsed or refractory (R/R) DLBCL after at least two prior therapies to regular approval. Read More


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