ONCOLOGY NEWSFEED

On August 28, the US Food and Drug Administration (FDA) approved luspatercept-aamt for the treatment of anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adult patients with very low to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell transfusions.

For more information read the Bristol Myers Squibb’s announcement .

Posted 8/31/2023

According to the ASHP (American Society of Health-System Pharmacists), shortages of vital prescription drugs are nearing all-time highs, and hospital and health-system pharmacists are reporting major challenges obtaining medications. In a new ASHP survey of more than 1,000 hospital pharmacists, 57% said they are facing critical shortages of chemotherapy drugs that are impacting patient care. Hospital pharmacists also report that significant shortages exist for steroids, hormonal drugs, and oral liquids, such as amoxicillin and lidocaine.

For more information read the ASHP press release .

Posted 8/16/2023

On August 14, the US Food and Drug Administration (FDA) approved HEPZATO KIT (melphalan for Injection/Hepatic Delivery System) containing melphalan (HEPZATO, Delcath Systems, Inc.) as a liver-directed treatment for adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.

For more information read the FDA announcement .

Posted 8/16/2023

On August 14, the US Food and Drug Administration (FDA) approved FoundationOne®CDx to be used as a companion diagnostic for Janssen Biotech, Inc. AKEEGA™ (niraparib and abiraterone acetate Dual Action Tablet), which was approved by the FDA for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC).

For more information read the Foundation Medicine Inc. announcement .

Posted 8/15/2023

On August 14, the US Food and Drug Administration (FDA) granted accelerated approval to elranatamab-bcmm, a bispecific B-cell maturation antigen directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

For more information read the FDA announcement and Pfizer announcement .

Posted 8/15/2023

On August 11, the US Food and Drug Administration (FDA) approved the fixed dose combination of niraparib and abiraterone acetate with prednisone, for adult patients with deleterious or suspected deleterious BRCA -mutated castration-resistant prostate cancer (mCRPC), as determined by an FDA-approved test.

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

Posted 8/15/2023

On August 9, the US Food and Drug Administration (FDA) granted accelerated approval to talquetamab-tgvs for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

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

Posted 8/15/2023

On August 9, the US Food and Drug Administration (FDA) approved pralsetinib for adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.

For more information read the FDA announcement .

Posted 8/10/2023

On August 2, the US Food and Drug Administration (FDA) approved trifluridine and tipiracil with bevacizumab, for metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy.

For more information read the FDA announcement .

Posted 8/2/2023

On July 31, the US Food and Drug Administration (FDA) approved dostarlimab-gxly with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for primary advanced or recurrent endometrial cancer that is mismatch repair deficient, as determined by an FDA-approved test, or microsatellite instability-high.

For more information read the FDA announcement and the GlaxoSmithKline announcement

Posted 8/2/2023

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

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

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

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

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

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

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

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

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

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

On May 4, the U.S. Food and Drug Administration (FDA) approved the FoundationOne ^® Liquid CDx to be used as a companion diagnostic for mobocertinib, which is currently FDA-approved for adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations, as detected by an FDA-approved test, and whose disease has progressed on or after platinum-based chemotherapy.

For more information, read the Foundation Medicine announcement .

Posted 5/4/2023

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

On April 17, the U.S Food and Drug Administration (FDA) approved omidubicel-onlv for use in adult and pediatric patients (12 years of age and older) with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.

For more information read the FDA announcement .

Posted 4/19/2023

On March 16, 2023, The U.S Food and Drug Administration approved a supplementary New Drug Application for Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection) to enable its use for the selection of patients with metastatic prostate cancer, for whom lutetium-177 (177Lu) PSMA-directed therapy is indicated.

For more information read the Telix Pharmaceuticals announcement .

Posted 3/29/2023