Industry News

FDA Approves Oral Suspension Ibrutinib in Adults with Chronic Lymphocytic Leukemia & Small Lymphocytic Lymphoma

On February 24, the US Food and Drug Administration (FDA) approved a label expansion for ibrutinib with an oral suspension formulation for adult patients in the treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma. Ibrutinib is now the only Bruton’s tyrosine kinase inhibitor (BTKi) approved with an oral suspension formulation.
For more information read the Johnson & Johnson announcement.
Posted 3/21/2024

FDA Approves Ponatinib + Chemotherapy for Lymphoblastic Leukemia

On March 19, the US Food and Drug Administration (FDA) granted accelerated approval to ponatinib in combination with chemotherapy for adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia.
For more information read the FDA announcement and the Takeda Pharmaceuticals announcement.
Posted 3/20/2024

FDA Approves Tislelizumabjsgr for the Treatment of Advanced or Metastatic Esophageal Squamous Cell Carcinoma

On March 14, the US Food and Drug Administration (FDA) approved tislelizumabjsgr as monotherapy for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma after prior systemic chemotherapy that did not include a PD-(L)1 inhibitor.
For more information read the BeiGene announcement.
Posted 3/15/2024

Changes to Ropeginterferon alfa-2b-njft in Updated NCCN Clinical Practice Guidelines

On February 27, PharmaEssentia, announced that the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®) have recently been updated to include ropeginterferon alfa-2b-njft, marketed as BESREMi®, as a preferred first-line cytoreductive therapy option for the treatment of adults with symptomatic, low-risk polycythemia vera.
For more information read the PharmaEssentia announcement.
Posted 3/13/2024

FDA Approves Zanubrutinib for Relapsed or Refractory Follicular Lymphoma

On March 7, the US Food and Drug Administration (FDA) granted accelerated approval to zanubrutinib in combination with obinutuzumab for relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
For more information read the FDA announcement and BeiGene announcement.
Posted 3/11/2024

FDA Approves Nivolumab + Cisplatin and Gemcitabine for Unresectable or Metastatic Urothelial Carcinoma

On March 6, the US Food and Drug Administration (FDA) approved nivolumab in combination with cisplatin and gemcitabine for first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.
For more information read the FDA announcement and the Bristol-Myers Squibb announcement.
Posted 3/11/2024

FDA Approves Inotuzumab Ozogamicin for Pediatric Patients with Acute Lymphoblastic Leukemia

On March 6, the US Food and Drug Administration (FDA) approved inotuzumab ozogamicin for pediatric patients 1 year and older with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia.
For more information read the FDA announcement.
Posted 3/8/2024

FDA Approves Amivantamab-vmjw for Non-small Cell Lung Cancer

On March 1, the US Food and Drug Administration (FDA) approved amivantamab-vmjw in combination with carboplatin and pemetrexed for the first-line treatment of 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.
For more information read the FDA announcement and the Janssen announcement.
Posted 3/8/2024

FDA Approves Osimertinib + Chemotherapy for EGFR-mutated Non-small Cell Lung Cancer

On February 16, the US Food and Drug Administration (FDA) approved osimertinib in combination with platinum-based chemotherapy for patients with locally advanced or metastatic non-small cell lung cancer 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 and the AstraZeneca Pharmaceuticals announcement.
Posted 2/19/2024

FDA Grants Accelerated Approval to Lifileucel for Unresectable or Metastatic Melanoma

On February 16, the US Food and Drug Administration (FDA) granted accelerated approval to lifileucel, a tumor-derived autologous T cell immunotherapy, for adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 positive, a BRAF inhibitor with or without a MEK inhibitor.
For more information read the FDA announcement and the Iovance Biotherapeutics, Inc. announcement.
Posted 2/19/2024