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

FDA Approves Isatuximab-irfc With Bortezomib, Lenalidomide, and Dexamethasone for Newly Diagnosed Multiple Myeloma

On September 20, the US Food and Drug Administration (FDA) approved isatuximab-irfc with bortezomib, lenalidomide, and dexamethasone for adults with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplant.

For more information read the FDA announcement and the Sanofi-Aventis US LLC announcement.

Posted on 9/23/2024

FDA Approves Amivantamab-vmjw With Carboplatin and Pemetrexed for Select Patients With Non-Small Cell Lung Cancer

On September 19, the US Food and Drug Administration (FDA) approved amivantamab-vmjw with carboplatin and pemetrexed for adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution mutations whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor.

For more information read the FDA announcement and the Johnson & Johnson announcement.

Posted on 9/20/2024

FDA Approves Pembrolizumab With Chemotherapy for Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma

On September 17, the US Food and Drug Administration (FDA) approved pembrolizumab with pemetrexed and platinum chemotherapy as first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma.

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

Posted on 9/19/2024

FDA Approves Ribociclib With an Aromatase Inhibitor and the Ribociclib and Letrozole Co-Pack for Early High-Risk Breast Cancer

On September 17, the US Food and Drug Administration (FDA) approved ribociclib with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor-positive, human epidermal growth factor receptor 2-negative stage II and III early breast cancer at high risk of recurrence. Additionally, FDA also approved the ribociclib and letrozole co-pack for the same indication.

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

Posted on 9/19/2024

FDA Approves Atezolizumab and Hyaluronidase-tqjs for Subcutaneous Injection

On September 12, the US Food and Drug Administration (FDA) approved atezolizumab and hyaluronidase-tqjs for subcutaneous injection for all the adult indications as the intravenous formulation of atezolizumab, including non-small cell lung cancer, small cell lung cancer, hepatocellular carcinoma, melanoma, and alveolar soft part sarcoma.

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

Posted on 9/19/2024

FDA Grants Fast Track Designation to BGB-16673

On August 26, the US Food and Drug Administration (FDA) granted Fast Track Designation to BGB-16673, an orally available investigational Bruton’s tyrosine kinase targeting chimeric degradation activation compound, for adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who have been previously treated with at least two prior lines of therapy, including BTK inhibitor and B-cell lymphoma 2 inhibitor.

For more information read the BeiGene announcement.

Posted on 8/26/2024

FDA Approves Lazertinib With Amivantamab-vmjw for Non-Small Cell Lung Cancer

On August 19, the US Food and Drug Administration (FDA) approved lazertinib in combination with amivantamab-vmjw for the first-line treatment of locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. 

For more information read the FDA announcement.

Posted on 8/21/2024

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

On August 15, the US Food and Drug Administration (FDA) approved durvalumab with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery 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 and the AstraZeneca announcement.

Posted on 8/21/2024

FDA Approves Axatilimab-csfr for Chronic Graft-Versus-Host Disease

On August 14, the US Food and Drug Administration (FDA) approved axatilimab-csfr, a colony stimulating factor-1 receptor-blocking antibody, for the treatment of chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing at least 40 kg.

For more information read the FDA announcement and the Incyte Corporation announcement.

Posted on 8/19/2024

FDA Approves Daratumumab and Hyaluronidase-fihj for Select Patients with Multiple Myeloma

On July 30, the US Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj in combination with bortezomib, lenalidomide and dexamethasone for induction and consolidation in patients with newly diagnosed multiple myeloma who are eligible for an autologous stem cell transplant. 

For more information read the FDA announcement and the Johnson & Johnson announcement.

Posted 7/31/2024

Updated NCCN Guidelines Recommend Imetelstat for Symptomatic Anemia in Select Patients

On July 26, Geron Corporation announced that the National Comprehensive Cancer Network (NCCN) has updated its Clinical Practice Guidelines in Oncology (NCCN Guidelines) for the treatment of to recommend RYTELO™ (imetelstat) as a Category 1 and 2A treatment of symptomatic anemia in patients with lower-risk Myelodysplastic Syndromes. Treatments are classified as Category 1 and 2A when there is uniform NCCN consensus ≥85% that the intervention is appropriate.

For more information read the Geron announcement.

Posted 7/26/2024

FDA Approves Repotrectinib for Patients with NTRK Gene Fusion-Positive Solid Tumors

On June 13, the US Food and Drug Administration (FDA) granted accelerated approval to repotrectinib for adult and pediatric patients 12 years and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and that have progressed following treatment or have no satisfactory alternative therapy.

For more information read the FDA announcement and the Bristol Meyers Squibb announcement.

Posted 7/2/2024 

FDA Grants Approves Epcoritamab-bysp for Relapsed or Refractory Follicular Lymphoma

On June 26, the US Food and Drug Administration (FDA) granted accelerated approval to epcoritamab-bysp, a bispecific CD20-directed CD3 T-cell engager, for adult patients with relapsed or refractory follicular lymphoma after 2 or more lines of systemic therapy.

FDA Approves Adagrasib + Cetuximab for KRAS G12C-Mutated Colorectal Cancer

On June 21, the US Food and Drug Administration (FDA) granted accelerated approval to adagrasib in combination with cetuximab for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan-based chemotherapy.

For more information read the FDA announcement and the Bristol Myers Squibb announcement. 

Posted 6/24/2024

FDA Approves Durvalumab + Chemotherapy for Endometrial Cancer

On June 17, the US Food and Drug Administration (FDA) approved durvalumab in combination with carboplatin and paclitaxel followed by durvalumab monotherapy, for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient. 

For more information read the AstraZeneca announcement. 

Posted 6/17/2024

FDA Approves Pembrolizumab + Chemotherapy for Primary Advanced or Recurrent Endometrial Carcinoma

On June 17, the US Food and Drug Administration (FDA) approved pembrolizumab in combination with carboplatin and paclitaxel, followed by single-agent pembrolizumab, for adult patients with primary advanced or recurrent endometrial carcinoma.

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

Posted 6/17/2024

FDA Approves Selpercatinib for RET Fusion-Positive Thyroid Cancer

On June 12, the US Food and Drug Administration (FDA) approved selpercatinib for adult and pediatric patients 2 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and are radioactive iodine-refractory (if radioactive iodine is appropriate).

For more information read the FDA announcement. 

Posted 6/13/2024

FDA Approves Imetelstat for Myelodysplastic Syndromes with Transfusion-Dependent Anemia

On June 6, the US Food and Drug Administration (FDA) approved imetelstat, an oligonucleotide telomerase inhibitor, for adults with low- to intermediate-1 risk myelodysplastic syndromes with transfusion-dependent anemia—requiring 4 or more red blood cell units over 8 weeks—who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents. 

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

Posted 6/7/2024

FDA Approves Lisocabtagene Maraleucel for Relapsed or Refractory Mantle Cell Lymphoma

On May 30, the US Food and Drug Administration (FDA) approved lisocabtagene maraleucel for adult patients with relapsed or refractory mantle cell lymphoma who have received at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor.

For more information read the FDA announcement and the Bristol Meyers Squibb announcement. 

Posted 6/4/2024