Oncology Newsfeed

FDA Approves Quizartinib for Newly Diagnosed AML

On July 20, the US Food and Drug Administration (FDA) approved quizartinib in combination 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-positive, as detected by an FDA-approved test.

For information read the FDA announcement and the Daiichi Sankyo, Inc. announcement. 

Posted 7/21/2023

FDA Approves Olaparib with Abiraterone and Prednisone (or Prednisolone) for BRCA-Mutated Metastatic Castration-Resistant Prostate Cancer

On May 31, 2023, the Food and Drug Administration approved olaparib (Lynparza, AstraZeneca Pharmaceuticals LP) with abiraterone and prednisone (or prednisolone) for adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved companion diagnostic test.

For more information read the FDA announcement.

Posted 6/22/2023

FDA Approves Talazoparib + Enzalutamide for HRR Gene-mutated Metastatic Castration-resistant Prostate Cancer

On June 20, the US Food and Drug Administration (FDA) approved talazoparib with enzalutamide for homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer. 

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

Posted 6/21/2023

FDA Grants Accelerated Approval to Glofitamab-gxbm

On June 15, the US Food and Drug Administration (FDA) granted accelerated approval to glofitamab-gxbm for relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after two or more lines of systemic therapy.

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

Posted 6/20/2023

Updated NCCN Clinical Practice Guidelines Provides a New Recommendation for Ropeginterferon alfa-2b-njft

On May 23, PharmaEssentia USA Corporation, a subsidiary of PharmaEssentia Corporation, announced that the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®) have been updated to include BESREMi® (ropeginterferon alfa-2b-njft) as a preferred therapeutic option for the treatment of adults with both high and low-risk polycythemia vera, regardless of treatment history. 

For more information read the PharmaEssentia announcement.

Posted 6/8/2023

FDA Approves Olaparib + Abiraterone and Prednisone for BRCA-mutated Metastatic Prostate Cancer

On May 31, the U.S Food and Drug Administration (FDA) approved olaparib with abiraterone and prednisone (or prednisolone) for adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer, as determined by an FDA-approved companion diagnostic test.

For more information read the FDA announcement.

Posted 5/31/2023

Coherus Announces U.S. Launch of UDENYCA® Autoinjector

On May 22, Coherus BioSciences, announced that the single-dose (6mg/0.6mL), prefilled autoinjector presentation of UDENYCA® (pegfilgrastim-cbqv) is now available for commercial sale in the United States. UDENYCA® is a pegfilgrastim biosimilar 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 5/30/2023

FDA Approves Avapritinib for the Treatment of Adult Patients with Indolent Systemic Mastocytosis

Blueprint Medicines is pleased to announce that AYVAKIT® (avapritinib) is now approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with indolent systemic mastocytosis (ISM). ISM is a rare mast cell disease that can lead to the proliferation and activation of abnormal mast cells which can affect multiple organ systems.1,2 ISM is driven by the KIT D816V mutation in about 95% of cases. It can be characterized by a range of symptoms, including skin, gastrointestinal, neurocognitive, and systemic symptoms (including anaphylaxis).2,6-8.

AYVAKIT is a tyrosine kinase inhibitor designed for the potent and selective inhibition of KIT D816V—the only FDA-approved treatment to selectively target the underlying driver of disease in ~95% of patients with ISM.3-5,9.

INDICATION

AYVAKIT® (avapritinib) is indicated for the treatment of adult patients with indolent systemic mastocytosis (ISM).

Limitations of Use: AYVAKIT is not recommended for patients with platelet counts of <50 x 109/L.

IMPORTANT SAFETY INFORMATION

There are no contraindications for AYVAKIT.

Intracranial Hemorrhage (ICH)—Serious ICH may occur with AYVAKIT treatment; fatal events occurred in <1% of patients. No events of ICH occurred in the 246 patients with ISM who received any dose of AYVAKIT in the PIONEER study. Monitor patients closely for risk factors of ICH which may include history of vascular aneurysm, ICH or cerebrovascular accident within the prior year, concomitant use of anticoagulant drugs, or thrombocytopenia. Symptoms of ICH may include headache, nausea, vomiting, vision changes, or altered mental status.

Advise patients to seek immediate medical attention for signs or symptoms of ICH. Permanently discontinue AYVAKIT if ICH of any grade occurs.

Cognitive Effects—Cognitive adverse reactions can occur in patients receiving AYVAKIT and occurred in 7.8% of patients with ISM who received AYVAKIT + best supportive care (BSC) versus 7.0% of patients who received placebo + BSC; <1% were Grade 3. Depending on the severity, withhold AYVAKIT and then resume at the same dose, or permanently discontinue AYVAKIT.

Photosensitivity—AYVAKIT may cause photosensitivity reactions. In all patients treated with AYVAKIT in clinical trials (n=1049), photosensitivity reactions occurred in 2.5% of patients. Advise patients to limit direct ultraviolet exposure during treatment with AYVAKIT and for one week after discontinuation of treatment.

Embryo-Fetal Toxicity—AYVAKIT can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females and males of reproductive potential to use an effective method of contraception during treatment with AYVAKIT and for 6 weeks after the final dose of AYVAKIT. Advise women not to breastfeed during treatment with AYVAKIT and for 2 weeks after the final dose.

Adverse Reactions—The most common adverse reactions (≥10%) in patients with ISM were eye edema, dizziness, peripheral edema, and flushing.

Drug Interactions—Avoid coadministration of AYVAKIT with strong or moderate CYP3A inhibitors or inducers. To report suspected adverse reactions, contact Blueprint Medicines Corporation at 1-888-258-7768 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please click here to see the full Prescribing Information for AYVAKIT.

Posted 5/24/2023

FDA Approves Avapritinib for Indolent Systemic Mastocytosis

On May 22, the U.S. Food and Drug Administration (FDA) approved avapritinib for the treatment of adults with indolent systemic mastocytosis.

For more information, read the Blueprint Medicines announcement.

Posted 5/24/2023

FDA Approves Epcoritamab-bysp for DLBCL

On May 19, the U.S. Food and Drug Administration (FDA) granted accelerated approval to epcoritamab-bysp  for the treatment of adult patients with for relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from indolent lymphoma and high-grade B-cell lymphoma after two or more lines of systemic therapy.

For more information read the FDA announcement and Genmab announcement.

Posted 5/22/2023