Vice President of Content, OncLive and Cancer Network
Gina Mauro is your lead editorial contact for OncLive. She joined the company in 2015 and has held various positions on OncLive; she is also the on-air correspondent for OncLive News Network: On Location. Prior to joining MJH Life Sciences, she worked at Gannett as a full-time reporter with the Asbury Park Press. Email: [email protected]
Due to its rarity, there will likely never be a television advertisement for Merkel cell carcinoma. Yet, several opportunities to help raise awareness and conduct an array of clinical trials are building, due to the disease’s response to checkpoint blockade.
The FDA has approved infigratinib for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring an FGFR2 fusion or rearrangement.
Experts in breast cancer, gynecologic malignancies, lung cancer, multiple myeloma, gastrointestinal cancers, and genitourinary cancers shared their perspectives on the biggest abstracts being presented at the 2021 ASCO Annual Meeting.
The European Commission has approved osimertinib for the adjuvant treatment of adult patients with early-stage EGFR-mutated non–small cell lung cancer following complete resection with curative intent.
The investigational PD-L1 inhibitor sugemalimab prolonged progression-free survival in patients with locally advanced, unresectable stage III non–small cell lung cancer without disease progression after concurrent or sequential chemoradiation.
Early detection and quick intervention of abdominal metastases in patients with osteosarcoma could be a tactic to improve patient outcomes as well as palliative care.
Effective early detection and optimal management are critical in preventing high-grade interstitial lung disease, a treatment-related adverse effect of fam-trastuzumab deruxtecan-nxki in patients with HER2-positive metastatic breast cancer.
Zanubrutinib demonstrated noninferiority in objective response rates and a trend toward improved progression-free survival when compared with ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia.
The FDA has granted a priority review designation to a new drug application for mobocertinib for the treatment of adult patients with EGFR exon 20 insertion mutation–positive metastatic non–small cell lung cancer, as detected via an FDA-approved assay, who have received previous platinum-based chemotherapy.
The FDA has granted an Orphan Drug designation to the investigational tumor-infiltrating lymphocyte therapy ITIL-168 for the treatment of patients with stage IIB to IV melanoma.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended osimertinib for the adjuvant treatment of adult patients with stage IB, II, or IIIA EGFR-mutated non–small cell lung cancer following complete tumor resection with curative intent.
The European Medicines Agency has validated a Type II Variation Marketing Authorization Application to Karyopharm Therapeutics Inc. for selinexor in combination with bortezomib and low-dose dexamethasone as a treatment for adult patients with multiple myeloma who have received at least 1 prior therapy.
The FDA has granted an accelerated approval to loncastuximab tesirine (Zynlonta) for the treatment of adult patients with relapsed/refractory large B-cell lymphoma following 2 or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, DLBCL arising from low-grade lymphoma, and high-grade B-cell lymphoma.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended the combination of nivolumab and ipilimumab as a frontline treatment for adult patients with unresectable malignant pleural mesothelioma.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has granted a positive opinion for the approval of oral azacitidine as a maintenance treatment for adult patients with acute myeloid leukemia who had a complete remission or CR with incomplete blood count recovery after induction therapy with or without consolidation treatment, and who are ineligible for or choose to not undergo hematopoietic stem cell transplant
The European Medicines Agency Committee for Medicinal Products for Human Use has recommended to approve venetoclax for use in combination with hypomethylating agents for the treatment of adult patients with newly diagnosed acute myeloid leukemia who are ineligible for intensive chemotherapy.
The European Commission has granted conditional marketing authorization to dostarlimab for the treatment of patients with microsatellite instability–high/mismatch repair deficient recurrent or advanced endometrial cancer who have progressed on or following prior therapy with a platinum-containing regimen.
The FDA has granted a priority review designation to SH-111, a sterile injectable therapy, for the treatment of pediatric patients with T-cell leukemia.
The FDA has approved the VENTANA MMR RxDx panel as a companion diagnostic assay to determine eligibility for dostarlimab-gxly as a treatment for patients with advanced or recurrent endometrial cancer whose tumors are mismatch repair deficient.
The frontline combination of toripalimab and cisplatin/paclitaxel reached its prespecified primary end points of progression-free and overall survival in patients with advanced esophageal squamous cell carcinoma in the phase 3 JUPITER-06 trial.
The FDA has granted an accelerated approval to dostarlimab-gxly (Jemperli) for the treatment of patients with recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing chemotherapy and whose cancers are mismatch repair deficient, as determined by an FDA-approved test.
Although the malignancy has an encouraging survival rate, it is necessary to be aware of the complexity of nasopharyngeal cancer.
The FDA granted a Regenerative Medicine Advanced Therapy designation to the allogeneic chimeric antigen receptor T-cell therapy as a potential treatment for patients with relapsed/refractory multiple myeloma.
The National Institute for Health and Care Excellence has published draft guidance that recommends fam-trastuzumab deruxtecan-nxki for the treatment of patients with unresectable or metastatic HER2-positive breast cancer following 2 or more anti-HER2 therapies.
As part of a resubmission plan for a biologics license application for omburtamab in pediatric patients with central nervous system and leptomeningeal metastasis from neuroblastoma, Y-mAbs, the manufacturer of the B7-H3–targeting monoclonal antibody, announced that it is collecting additional granularity data requested by the FDA and anticipates submitting them to the regulatory agency by the end of April 2021.
Reattaching the greater trochanter to the proximal femur endoprosthesis did not show an improvement in Trendelburg gait or reliance on an assistive ambulatory device vs a soft tissue–only abductor repair in patients with bone cancers.
AFM13, an innate cell engager, demonstrated an objective response rate of 100% in adult patients with CD30-positive, relapsed/refractory Hodgkin lymphoma.
The combination of the selective MCL-1 inhibitor AMG 176 plus gilteritinib was found to synergistically target preclinical models of FLT3 internal tandem duplication–mutated acute myeloid leukemia.
Nivolumab in combination with paclitaxel showed clinical activity and a manageable safety profile when used as second-line therapy for patients with Epstein-Barr virus–related, microsatellite instability–high/mismatch repair deficient or PD-L1–positive advanced gastric cancer.
The combination of copanlisib and rituximab was associated with a 48% reduction in the risk of disease progression or death compared with rituximab plus placebo in patients with relapsed indolent non-Hodgkin lymphoma.
