FDA Approves Obecabtagene autoleucel for Adults With Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia

Posted on 11/14/2024

On November 8, the US Food and Drug Administration (FDA) approved obecabtagene autoleucel, a CD19-directed genetically modified autologous T cell immunotherapy, for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

For more information read the FDA announcement and visit the Autolus website.

Anemia in Focus: The Challenge of Identifying Myelodysplastic Syndromes (MDS)

Posted on 11/09/2024

Anemia is a hallmark of MDS, conferring heightened mortality risk and diminished quality of life. Please feel free to view & share this important resource.
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FDA Grants Accelerated Approval to Asciminib for Newly Diagnosed Chronic Myeloid Leukemia

Posted on 10/29/2024

On October 29, the US Food and Drug Administration (FDA) granted accelerated approval to asciminib for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase.

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

New Insurance Codes for Scalp Cooling Will Transform Access for Cancer Patients

On October 18, the American Medical Association introduced new Category I Current Procedural Terminology codes for scalp cooling services, effective January 2026. This change will enhance insurance reimbursement, making scalp cooling more accessible to cancer patients undergoing chemotherapy.

For more information read the PR Newswire announcement.

Posted on 10/24/2024

FDA Approves Novocure’s Optune Lua® for the Treatment of Metastatic Non-Small Cell Lung Cancer

On October 15, the US Food and Drug Administration (FDA) has approved Optune Lua® for concurrent use with PD-1/PD-L1 inhibitors or docetaxel, for the treatment of adult patients with metastatic non-small cell lung cancer who have progressed on or after a platinum-based regimen.

For more information read the Novocure announcement.

Posted on 10/24/2024

FDA Approves Zolbetuximab-clzb With Chemotherapy for Gastric or Gastroesophageal Junction Adenocarcinoma

Posted on 10/21/2024

On October 18, US the Food and Drug Administration (FDA) approved zolbetuximab-clzb, a claudin 18.2 (CLDN18.2)-directed cytolytic antibody, with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2 positive, as determined by an FDA-approved test.

For more information read the FDA announcement and the Astellas Pharma US announcement.

FDA Approves Inavolisib With Palbociclib and Fulvestrant for Select Patients With Breast Cancer

On October 10, the US Food and Drug Administration (FDA) approved inavolisib with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor-positive, human epidermal growth-factor receptor 2-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy.

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

Posted on 10/17/2024

FDA Approves Neoadjuvant/Adjuvant Nivolumab for Resectable Non-Small Cell Lung Cancer

On October 3, the US Food and Drug Administration (FDA) approved nivolumab with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent nivolumab after surgery as adjuvant treatment, for adults with resectable non-small cell lung cancer and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements. 

For more information read the FDA announcement.

Posted on 10/8/2024

FDA Approves Selpercatinib for Medullary Thyroid Cancer With a RET Mutation

On September 27, the US Food and Drug Administration (FDA) granted traditional approval to selpercatinib for adult and pediatric patients 2 years of age and older with advanced or metastatic medullary thyroid cancer with a RET mutation, as detected by an FDA-approved test, who require systemic therapy.

For more information read the FDA announcement.

Posted on 10/7/2024

FDA Approves Osimertinib for Locally Advanced, Unresectable Non-Small Cell Lung Cancer Following Chemoradiation Therapy

On September 25, the US Food and Drug Administration (FDA) approved osimertinib for adult patients with locally advanced, unresectable (stage III) non-small cell lung cancer whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.

For more information read the FDA announcement.

Posted on 9/26/2024