ONCOLOGY NEWSFEED

On October 19, the FDA approved dostarlimab for adults with Stage II/III locally advanced rectal cancer that is microsatellite instability high or mismatch repair deficient, as determined by an FDA-authorized test for solid tumors.

For more information, read the FDA announcement and the GSK press release.

On October 14, the FDA approved nogapendekin alfa inbakicept-pmln in combination with Bacillus Calmette-Guérin (BCG) for adults with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). This revises the prior indication for adults with BCG-unresponsive NMIBC with carcinoma in situ with or without papillary tumors to include patients with high-grade papillary-only tumors.

For more information, read the FDA announcement.

On September 14, the FDA approved a label update for tarlatamab-dlle for the treatment of adult patients with extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy.

This approval means that patients receiving tarlatamab-dlle should now be monitored for six to eight hours from the start of their first two infusions, compared with the previously recommended 22 to 24 hours.

For more information, read the Amgen press release.

On October 8, the FDA approved atezolizumab in combination with fluoropyrimidine and oxaliplatin for the adjuvant treatment of adult and pediatric patients two years of age and older with Stage III mismatch repair deficient (dMMR) colon cancer. The FDA also approved atezolizumab and hyaluronidase-tqjs in combination with fluoropyrimidine and oxaliplatin for the adjuvant treatment of adult and pediatric patients 12 years of age and older who weigh 40 kg or greater with Stage III dMMR colon cancer.

For more information, read the FDA announcement and the Genentech press release.

On October 7, the FDA approved tucatinib in combination with trastuzumab and pertuzumab for the maintenance treatment of adults with unresectable locally advanced or metastatic HER2-positive breast cancer following induction treatment.

For more information, read the FDA announcement and the Pfizer press release.

On October 2, the FDA approved pirtobrutinib for adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma with no known 17p deletion.

For more information, read the FDA announcement and the Eli Lilly press release.

On September 30, Celcuity announced that gedatolisib is now commercially available in the United States for eligible patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.

For more information, read the Celcuity press release.

On September 24, the FDA approved belzutifan in combination with lenvatinib for adults with advanced renal cell carcinoma with a clear cell component following a programmed death receptor-1 or programmed death-ligand 1 inhibitor.

For more information, read the FDA announcement and the Eisai press release.

On September 23, the FDA approved lirafugratinib, a kinase inhibitor, for the treatment of adults with previously treated unresectable, locally advanced or metastatic cholangiocarcinoma harboring a fibroblast growth factor receptor 2 gene fusion or other rearrangement.

For more information, read the FDA announcement and the Elevar Therapeutics press release.

On September 18, the FDA granted full approval to imlunestrant, an oral estrogen receptor antagonist, in combination with abemaciclib, a CDK4/6 inhibitor, for the treatment of adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated locally advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy.

For more information, read the Eli Lilly press release.

On September 9, the FDA granted accelerated approval to sevabertinib, a kinase inhibitor, for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test.

For more information, read the FDA announcement and the Bayer press release.

On September 4, the FDA granted accelerated approval to camizestrant, an estrogen receptor antagonist, in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for adults with hormone receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer upon detection of estrogen receptor-1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test.

For more information, read the FDA announcement and the AstraZeneca press release.

On August 26, the FDA approved daraxonrasib, an inhibitor of the RAS GTPase family, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy.

For more information, read the FDA announcement and the Revolution Medicines press release.

On August 25, the FDA approved zanidatamab-hrii:

in combination with fluoropyrimidine- and platinum-containing chemotherapy and tislelizumab-jsgr, as first-line treatment for adults with HER2-positive (IHC 3+ or IHC 2+/ISH+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, as detected by an FDA-approved test, and

in combination with fluoropyrimidine-, and platinum-containing chemotherapy, as first-line treatment for adults with HER2-positive (IHC 3+) unresectable locally advanced or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, as detected by an FDA-approved test.

The FDA also approved two companion diagnostic devices, the PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody and the VENTANA HER2 Dual ISH DNA Probe Cocktail, for identifying patients with HER2-positive (IHC3+ or IHC2+/ISH+) gastric, gastroesophageal junction, and esophageal adenocarcinoma for treatment with Ziihera, consistent with the approved drug labeling.

For more information, read the FDA announcement and the Jazz Pharmaceuticals press release.

On August 13, the FDA granted accelerated approval to iberdomide in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy including a proteasome inhibitor and an immunomodulatory agent.

For more information, read the FDA announcement and the Bristol-Myers Squibb press release.

On August 6, the FDA granted accelerated approval to vusolimogene oderparepvec-wtpg, a genetically modified oncolytic viral therapy, in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression on a programmed death receptor-1-blocking antibody-based regimen.

For more information, read the FDA announcement and the Replimune press release.

On July 31, the FDA approved lutetium Lu 177 vipivotide tetraxetan in combination with androgen receptor pathway inhibitor therapy for adults with prostate-specific membrane antigen-positive metastatic androgen pathway modulation-naïve or-sensitive prostate cancer.

For more information, read the FDA announcement and the Novartis press release.

On July 22, the FDA approved zidesamtinib, an ROS1 selective inhibitor, for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer who received a prior ROS1 kinase inhibitor.

For more information, read the FDA announcement and the GSK press release.

On July 14, the FDA approved gedatolisib in combination with fulvestrant, with or without palbociclib, for adults with hormone receptor-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting.

For more information, read the FDA announcement and the Celcuity press release.

On July 14, the FDA granted traditional approval to selpercatinib for adult and pediatric patients two years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.

For more information, read the FDA announcement and visit the Eli Lilly website.

On July 10, the FDA approved pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, each in combination with enfortumab vedotin-ejfv as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle invasive bladder cancer.

For more information, read the FDA announcement and the Merck press release.

On July 9, the FDA approved Isatuximab-Irfc Forisatuxi for subcutaneous injection for multiple myeloma indications.

For more information, read the FDA announcement and the Sanofi-Aventis press release.

On June 30, the FDA approved TREGZI™, an allogeneic regulatory T cell-based immunotherapy with hematopoietic stem and progenitor cell and T cells-vldq, for use in matched donor hematopoietic stem cell transplantation with a myeloablative preparative regimen, for hematopoietic and immunologic reconstitution and to improve chronic graft-versus-host disease-free survival, in the treatment of adults with hematological malignancies.

For more information, read the FDA announcement and the Orca Bio press release.

On June 24, the FDA approved sacituzumab govitecan-hziy for 2 indications in adults with triple-negative breast cancer.

For more information, read the FDA announcement and the Gilead press release.