ONCOLOGY NEWSFEED

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 .

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 .

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 .

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 .

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 .

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

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

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

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.

For more information read the FDA announcement and the Genmab Inc. announcement .

Posted 6/27/2024

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

Posted on 06.17.2024

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 on 06.17.2024

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 .

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

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 .

On May 15, the US Food and Drug Administration (FDA) granted accelerated approval to lisocabtagene maraleucel for adults with relapsed or refractory follicular lymphoma who have received 2 or more prior lines of systemic therapy.

For more information read the FDA announcement .

Posted 5/16/2024

On April 29, the US Food and Drug Administration (FDA) granted traditional approval to tisotumab vedotin-tftv for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tisotumab vedotin-tftv previously received accelerated approval for this indication.

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

Posted 4/30/2024

On April 23, the US Food and Drug Administration (FDA) approved lutetium Lu 177 dotatate for pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors.

For more information read the FDA announcement .

Posted 4/24/2024

On April 22, the US Food and Drug Administration approved nogapendekin alfa inbakicept-pmln in combination with Bacillus Calmette-Guérin (BCG) for adult patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ with or without papillary tumors.

For more information read the FDA announcement .

Posted 4/23/2024

On April 18, the US Food and Drug Administration (FDA) approved alectinib for adjuvant treatment following tumor resection in patients with anaplastic lymphoma kinase-positive non-small cell lung cancer, as detected by an FDA-approved test.

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

Posted 4/18/2024

On April 5, the US Food and Drug Administration (FDA) granted accelerated approval to fam-trastuzumab deruxtecan-nxki for adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options.

For more information read the FDA announcement .

Posted 4/8/2024

On March 22, the US Food and Drug Administration (FDA) approved mirvetuximab soravtansine-gynx for adult patients with FRα positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received 1 to 3 prior systemic treatment regimens.

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

Posted 3/25/2024

On March 21, 2024, the US Food and Drug Administration (FDA) approved safety labeling changes for fluorouracil injection products. This effort was a collaboration between FDA’s Office of Generic Drugs and the Oncology Center of Excellence.

For more information read the FDA announcement .

Posted 3/21/2024

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

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