SITC Press Releases

In cooperation with the Food and Drug Administration (FDA), and as a service to our members, SITC will periodically distribute information about newly approved therapies for cancer patients. This helps the FDA inform oncologists and professionals in oncology-related fields of recent approvals in a timely manner. Included in the email from the FDA will be a link to the product label, which will provide the relevant clinical information on the indication, contraindications, dosing, and safety. In sending this information, SITC does not endorse any product or therapy and does not take any position ...
0 comments
On January 12, 2024, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with chemoradiotherapy (CRT) for patients with FIGO 2014 Stage III-IVA cervical cancer. Full prescribing information for Keytruda will be posted here . Efficacy was evaluated in KEYNOTE-A18 (NCT04221945), a multicenter, randomized, double-blind, placebo-controlled trial enrolling 1060 patients with cervical cancer who had not previously received definitive surgery, radiation, or systemic therapy. The trial included 596 patients with FIGO 2014 Stage III-IVA disease and 462 patients with FIGO 2014 ...
0 comments
On October 31, 2023, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) to be used with gemcitabine and cisplatin for locally advanced unresectable or metastatic biliary tract cancer (BTC). View full prescribing information for Keytruda . Efficacy was evaluated in KEYNOTE-966 (NCT04003636), a multicenter, randomized, double-blind, placebo-controlled trial that enrolled 1069 patients with locally advanced unresectable or metastatic BTC who had not received prior systemic therapy for advanced disease. Patients were randomized (1:1) to receive either pembrolizumab on Day ...
0 comments
On October 27, 2023, the Food and Drug Administration approved toripalimab-tpzi (LOQTORZ, Coherus BioSciences, Inc.) with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (NPC). FDA also approved toripalimab-tpzi as a single agent for adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy. View full prescribing information for LOQTORZI . Efficacy of toripalimab-tpzi with cisplatin and gemcitabine was evaluated in JUPITER-02 (NCT03581786), ...
0 comments
SITC Announces Late-Breaking Abstracts and Press Briefing Presented at 38 th Annual Meeting The Society for Immunotherapy of Cancer (SITC) received a record-breaking number of abstract submissions in 2023, more than 1,600, and has announced titles and authors for 30 accepted Late-Breaking abstracts (LBA). The abstracts will be presented at SITC’s upcoming 38 th Annual Meeting & Pre-Conference Programs taking place November 1–5, 2023, in San Diego, CA and virtually. SITC also invites you to attend the virtual press briefing of the society’s 38 th Annual Meeting (SITC ...
0 comments
Society for Immunotherapy of Cancer Publishes Clinical Practice Guideline Immunotherapy for Melanoma, V3.0 MILWAUKEE – The Society for Immunotherapy of Cancer (SITC), the world’s leading member-driven organization dedicated to improving patient outcomes by advancing the science and application of cancer immunotherapy, is pleased to announce the publication of a new clinical practice guideline (CPG) focused on immunotherapy for the treatment of melanoma. The manuscript, “ Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of melanoma, ...
0 comments
On October 16, 2023, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) with platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent pembrolizumab as post-surgical adjuvant treatment for resectable (tumors ≥4 cm or node positive) non-small cell lung cancer (NSCLC). View full prescribing information for Keytruda . Efficacy was evaluated in KEYNOTE-671 (NCT03425643), a multicenter, randomized, double-blind, placebo-controlled trial in 797 patients with previously untreated and resectable Stage II, IIIA, or IIIB (N2) NSCLC by AJCC ...
0 comments
On October 13, 2023, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) for the adjuvant treatment of completely resected Stage IIB/C melanoma in patients 12 years and older. View full prescribing information for Opdivo . Efficacy was evaluated in CHECKMATE-76K (NCT04099251), a randomized, double-blind trial enrolling 790 patients with Stage IIB/C melanoma. Patients were randomized (2:1) to nivolumab 480 mg or placebo by intravenous infusion every 4 weeks for up to 1 year or until disease recurrence or unacceptable toxicity. Enrollment required complete ...
0 comments
The Society for Immunotherapy of Cancer and the International Bladder Cancer Group Publish Recommendations for Clinical Trial Design in Bladder Cancer MILWAUKEE – The Society for Immunotherapy of Cancer (SITC) and the International Bladder Cancer Group (IBCG) are pleased to announce the publication of the “ Definitions, End Points, and Clinical Trial Designs in Bladder Cancer: Recommendations from the Society for Immunotherapy of Cancer and the International Bladder Cancer Group ” manuscript. Published in the Journal of Clinical Oncology , this manuscript includes clinical trial design ...
0 comments
FOR IMMEDIATE RELEASE Aug. 16, 2023 MILWAUKEE – In its mission to make “cure” a reality for cancer patients everywhere, the Society for Immunotherapy of Cancer (SITC) Forward Fund is pleased to announce the recipients of the 2023 Fellowships. “These fellowship recipients are the future of cancer immunotherapy and SITC is thrilled to be able to support these individuals and their novel research,” said SITC President Leisha A. Emens, MD, PhD. “We sincerely thank our industry partners who help make the SITC Fellowship program possible.” The 2023 Fellowships are financially ...
0 comments
On August 14, 2023, the Food and Drug Administration granted accelerated approval to elranatamab-bcmm (Elrexfio, Pfizer, Inc.), a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. View full prescribing information for Elrexfio. Efficacy was evaluated in MagnetisMM-3 (NCT04649359), an open-label, single-arm, multi-center study that included patients with relapsed/refractory ...
0 comments
On August 9, 2023, the Food and Drug Administration granted accelerated approval to talquetamab-tgvs (Talvey, Janssen Biotech, Inc.) for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. View full prescribing information for Talvey Efficacy was evaluated in MMY1001 (MonumenTAL-1) (NCT03399799, NCT4634552), a single-arm, open-label, multicenter study that included 187 patients who had previously received at least four prior systemic therapies. ...
0 comments
On July 31, 2023, the Food and Drug Administration approved dostarlimab-gxly (Jemperli, GlaxoSmithKline) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for primary advanced or recurrent endometrial cancer (EC) that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H). View full prescribing information for Jemperli. Efficacy was evaluated in RUBY (NCT03981796), a randomized, multicenter, double-blind, placebo-controlled trial. Efficacy was assessed in a pre-specified subgroup of 122 patients with ...
0 comments
Society for Immunotherapy of Cancer Publishes Clinical Practice Guideline on Immunotherapy for the Treatment of Gynecologic Cancer MILWAUKEE – The Society for Immunotherapy of Cancer (SITC), the world’s leading member-driven organization dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy, has published the first clinical practice guideline (CPG) focused on immunotherapy for the treatment of gynecologic cancer. The new manuscript, “ Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the ...
0 comments
Society for Immunotherapy of Cancer Publishes Clinical Practice Guideline on Immunotherapy for the Treatment of Gastrointestinal Cancer MILWAUKEE – The Society for Immunotherapy of Cancer (SITC), the world’s leading member-driven organization dedicated to improving cancer patient outcomes by advancing the science and application of cancer immunotherapy, is pleased to announce the publication of a new clinical practice guideline (CPG) focused on immunotherapy for the treatment of gastrointestinal cancer . The manuscript, “ Society for Immunotherapy of Cancer (SITC) clinical practice ...
0 comments