FDA Grants Tucatinib Breakthrough Designation for HER2+ Breast Cancer
December 18th 2019The FDA has granted tucatinib a breakthrough therapy designation for use in combination with trastuzumab and capecitabine for the treatment of patients with unresectable locally advanced or metastatic HER2-positive breast cancer, including patients with brain metastases, who had prior trastuzumab, pertuzumab, and ado-trastuzumab emtansine.
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FDA Panel Supports Pembrolizumab for High-Risk NMIBC
December 18th 2019The FDA’s Oncologic Drugs Advisory Committee voted in support of approving pembrolizumab for the treatment of patients with Bacillus Calmette-Guerin–unresponsive, high-risk, non-muscle invasive bladder cancer with carcinoma in-situ with or without papillary tumors who are ineligible for or chose to not undergo cystectomy.
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FDA Approval Sought for Belantamab Mafodotin in Relapsed/Refractory Myeloma
December 17th 2019A biologics license application has been filed with the FDA for belantamab mafodotin for the treatment of patients with relapsed or refractory multiple myeloma whose prior therapy included an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody.
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Analysis Unable to Achieve Concordance Among PD-L1 Assays in TNBC
December 16th 2019Mathematical modeling was unable to harmonize the VENTANA SP263 and Dako 22C3 PD-L1 assays with the FDA-approved VENTANA PD-L1 SP142 companion diagnostic for the selection of patients with advanced triple-negative breast cancer appropriate for atezolizumab plus nab-paclitaxel.
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Neoadjuvant Olaparib Combo Safe in Breast Cancer
December 14th 2019Adding the PARP inhibitor olaparib to neoadjuvant platinum based-chemotherapy was determined to be a safe treatment for patients with triple-negative breast cancer, as well as for patients with breast cancer whose tumors harbor germline BRCA mutations.
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Adjuvant T-DM1 Benefit in HER2+ Breast Cancer Observed Across Key Subgroups
December 14th 2019The invasive disease-free survival benefit with adjuvant T-DM1 versus trastuzumab in patients with HER2-positive early breast cancer who had residual invasive disease following neoadjuvant therapy was observed regardless of the type of neoadjuvant chemotherapy used.
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Extended Follow-Up Shows Continued Olaparib Benefit in BRCA+ MBC
December 13th 2019Olaparib continued to show a numerical overall survival (OS) benefit with a favorable hazard ratio for OS versus chemotherapy in patients with BRCA-positive, HER2-negative metastatic breast cancer, according to an extended, exploratory follow-up analysis of the phase III OlympiAD trial.
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Survival Benefit Hinted at With Durvalumab Maintenance in TNBC
December 13th 2019Maintenance durvalumab may improve outcomes versus chemotherapy in patients with triple-negative breast cancer or those with PD-L1–positive breast cancer across several subtypes, according to exploratory analyses from the phase II randomized SAFIR02-IMMUNO trial presented at the 2019 San Antonio Breast Cancer Symposium.
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Palbociclib Real-World Results Indicate OS Benefit in Frontline HR+/HER2- Breast Cancer
December 12th 2019Real-world data for frontline palbociclib indicate that the positive progression-free survival data observed with the CDK4/6 inhibitor in the pivotal PALOMA-2 trial would likely translate to an overall survival benefit in patients with HR-positive/HER2-negative metastatic breast cancer
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Margetuximab Update Elucidates Clinical Benefit in HER2+ Metastatic Breast Cancer
December 12th 2019Margetuximab continued to show a clear progression-free survival benefit and a trend toward an overall survival benefit versus trastuzumab (Herceptin) when either agent was combined with chemotherapy in patients with HER2-positive metastatic breast cancer who had received prior anti-HER2 therapies.
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Tucatinib Boosts Survival in HER2+ Breast Cancer, FDA Submission Imminent
December 12th 2019Adding tucatinib to trastuzumab (Herceptin) and capecitabine (Xeloda) reduced the risk of death by 34% in heavily pretreated patients with unresectable locally advanced or metastatic HER2-positive breast cancer.
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Daratumumab Plus Carfilzomib and Dexamethasone Extends PFS in Relapsed/Refractory Myeloma
December 10th 2019Adding daratumumab (Darzalex) to carfilzomib (Kyprolis) and dexamethasone reduced the risk of disease progression or death by 37% compared with carfilzomib and dexamethasone alone in patients with relapsed/refractory multiple myeloma.
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Atezolizumab Plus Bevacizumab Extends Survival in Frontline HCC
November 23rd 2019The frontline combination of atezolizumab (Tecentriq) and bevacizumab (Avastin) reduced the risk of disease progression or death by 42% compared with sorafenib (Nexavar) in patients with unresectable hepatocellular carcinoma.
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EU Panel Backs Polatuzumab Vedotin Approval for DLBCL
November 15th 2019The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of the antibody-drug conjugate polatuzumab vedotin for use in combination with bendamustine and rituximab for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma who are not candidates for a hematopoietic stem cell transplant.
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Adjuvant T-DM1 Approaches EU Approval for HER2+ Early Breast Cancer
November 15th 2019The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended approval of trastuzumab emtansine for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease (breast and/or lymph nodes) following neoadjuvant taxane-based chemotherapy and HER2-targeted therapy.
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Avelumab Falls Short as Frontline Maintenance for Gastric/GEJ Cancer
November 9th 2019Avelumab did not improve overall survival as frontline maintenance following induction chemotherapy in patients with unresectable, locally advanced, or metastatic HER2-negative gastric or gastroesophageal junction cancer.
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Anti-BCMA Approaches Ascending in Multiple Myeloma
November 7th 2019Anti-BCMA directed treatments, including CAR T-cell therapy, bispecific antibodies, and antibody-drug conjugates, have the potential to revolutionize the multiple myeloma treatment paradigm. At the 37 Annual CFS®, Sham Mailankody, MBBS, discussed the emerging BCMA-directed therapies that have shown the greatest potential.
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Umbralisib Hits Primary Endpoint in Follicular Lymphoma Subgroup of Pivotal Study
October 29th 2019Umbralisib (TGR-1202) met the primary endpoint of overall response rate in the follicular lymphoma cohort of the pivotal phase IIb UNITY-NHL trial, according to TG Therapeutics, Inc., the developer of the PI3K-delta inhibitor.
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EU Panel Backs Pembrolizumab Regimens for Frontline HNSCC
October 18th 2019The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of pembrolizumab as a monotherapy or in combination with platinum and 5-FU as frontline treatment for patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma and PD-L1 expression on their tumors.
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FDA Label Update Supports Earlier Use of Romiplostim for ITP
October 18th 2019The FDA has approved a supplemental Biologics License Application for romiplostim, updating its label to include data demonstrating sustained platelet responses in adults with immune thrombocytopenia. Romiplostim is approved for the treatment of adult patients with newly diagnosed or persistent who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
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Daratumumab Triplet Nears EU Approval for Frontline Transplant-Ineligible Myeloma
October 18th 2019The European Medicines Agency's Committee for Medicinal Products for Human Use has backed approval of daratumumab for use in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation.
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