Web Exclusives

Web Exclusives | March 20, 2020

Danelle Johnston, MSN, RN, HON-ONN-CG, OCN, and Tricia Strusowski, RN, MS, recapped their recent presentation from the ACCC 46th Annual Meeting & Cancer Center Business Summit, in which they discussed the National Evidence-Based Oncology Navigation Metrics: Multisite Exploratory Study to Demonstrate Value and Sustainability of Navigation Programs. The study was launched in June 2018 as a collaborative effort between the Academy of Oncology Nurse & Patient Navigators (AONN+), Chartis Oncology Solutions, and the American Cancer Society (ACS).

Web Exclusives | February 11, 2020
Pivotal phase 3 data demonstrated treatment with luspatercept resulted in statistically significant increased red blood cell transfusion independence compared with placebo.
Web Exclusives | February 4, 2020
On January 29, 2020, Eli Lilly announced that the FDA granted priority review to their New Drug Application for selpercatinib (LOXO-292) for the treatment of patients with advanced RET fusion-positive non–small-cell lung cancer, RET-mutant medullary thyroid cancer, and RET fusion-positive thyroid cancer. The FDA is aiming to provide its decision on the approval of selpercatinib in the third quarter of 2020.
Web Exclusives | January 20, 2020
The American Cancer Society reports good news regarding the overall lower rate of cancer-related mortalities in the United States, but also points to some disturbing trends.
Web Exclusives | January 13, 2020
The FDA approval of avapritinib marks the first time a drug has been approved specifically for patients with GIST harboring PDGFRA exon 18 mutations, which are involved in approximately 10% of GIST cases.
Web Exclusives | January 7, 2020
The FDA has confirmed another strong year regarding the approval of innovative new drugs and biosimilars, including several agents used in the treatment of patients with cancer.
Web Exclusives | December 16, 2019
On December 12, 2019, the FDA issued draft guidance to implement amendments to the Federal Food, Drug, and Cosmetic (FD&C) Act that will facilitate early assessment of studies of molecularly targeted oncology drugs that may be effective in the treatment of pediatric cancers.
Web Exclusives | December 11, 2019
On December 3, 2019, the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to the biopharmaceutical company Adaptimmune Therapeutics for ADP-A2M4 for the treatment of synovial sarcoma. Earlier this year, the FDA granted Orphan Drug designation to the agent for the treatment of soft tissue sarcomas.
Web Exclusives | December 3, 2019
The FDA has granted priority review to Merck’s supplemental Biologics License Application for the anti-PD–1 agent pembrolizumab as monotherapy for certain patients with high-risk, non-muscle invasive bladder cancer who are ineligible for or have elected not to undergo cystectomy.
Web Exclusives | November 25, 2019
  • Calquence Receives FDA Approval for the Treatment of Patients with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
  • Despite Some Positive Trends, Report Confirms Lung Cancer Remains the Deadliest Form of Cancer
Web Exclusives | November 25, 2019

On November 15, 2019, the FDA approved crizanlizumab (Adakveo; Novartis) to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients aged ≥16 years with sickle-cell disease.

Web Exclusives | November 18, 2019
  • Teva Will Resume Production of Vincristine in Response to Shortage
  • FDA Fast-Tracks Opdivo plus Yervoy Regimen for Treatment of Advanced Liver Cancer
  • FDA Grants Accelerated Approval to Brukinsa for Patients with Mantle-Cell Lymphoma
Web Exclusives | November 11, 2019
  • FDA Approves Ziextenzo, Third Biosimilar to Pegfilgrastim for Febrile Neutropenia
  • Trump Will Nominate Dr Hahn as Next FDA Commissioner
  • Researchers Report High Rates of E-Cigarette Use Among Children and Teens
Web Exclusives | November 5, 2019
  • Xospata Extends Overall Survival in Patients with FLT3 Mutation–Positive Relapsed or Refractory Acute Myeloid Leukemia
  • Published Results from KEYNOTE-048 Trial Show Extended Survival with Keytruda in Advanced Head and Neck Cancers
  • Discussing Costs of Genomic Testing with Patients
Web Exclusives | October 28, 2019
  • Zejula Now Approved for Late-Line Ovarian Cancer
  • Trump Set to Nominate Hahn as FDA Commissioner
  • FDA Aims to Improve Breast Implant Guidance
Web Exclusives | October 22, 2019
The past week in oncology-related news includes shortages of crucial pediatric cancer drug, results of a study of racial disparities in multiple myeloma, and new drug on the horizon for HER2 metastatic breast cancer.
Web Exclusives | September 27, 2019
On September 26, 2019, the FDA approved daratumumab (Darzalex; Janssen) in combination with bortezomib, thalidomide, and dexamethasone for the treatment of newly diagnosed patients with multiple myeloma who are eligible for autologous stem-cell transplant (ASCT). The FDA granted this application priority review.
Web Exclusives | June 26, 2019
Lung cancer is the second most frequently diagnosed malignancy in both men and women (following prostate and breast cancer, respectively), and the leading cause of cancer deaths overall. Non–small-cell lung cancer (NSCLC) is the most common type, with the more aggressive small-cell lung cancer (SCLC) making up approximately 10% to 15% of cases.
Web Exclusives | June 12, 2019
On June 10, 2019, the US Food and Drug Administration (FDA) granted accelerated approval to the novel antibody-drug conjugate polatuzumab vedotin-piiq (Polivy; Genentech) in combination with bendamustine plus rituximab for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least 2 previous therapies. This is the first chemoimmunotherapy regimen approved for use in patients with DLBCL who are ineligible for hematopoietic stem-cell transplantation.
Web Exclusives | May 14, 2019
On May 3, 2019, the US Food and Drug Administration (FDA) approved ado-trastuzumab emtansine (Kadcyla; Genentech) for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. Patients should be selected for treatment with this agent based on an FDA-approved companion diagnostic test (Ventana Medical System’s PATHWAY anti-HER-2/neu [4B5] Rabbit Monoclonal Primary Antibody assay or INFORM HER2 Dual ISH DNA Probe Cocktail assay).
Web Exclusives | May 7, 2019
On May 2, 2019, the US Food and Drug Administration (FDA) approved ivosidenib (Tibsovo; Agios Pharmaceuticals, Inc) for the treatment of newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved companion diagnostic test, in patients who are aged ≥75 years or who have comorbidities that preclude the use of intensive induction chemotherapy.
Web Exclusives | April 5, 2019
On April 4, 2019, the US Food and Drug Administration (FDA) expanded the indication of palbociclib (Ibrance; Pfizer), a kinase inhibitor, in combination with specific endocrine therapies for men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. This is the first hormonal-based therapy to be approved for men.
Web Exclusives | April 1, 2019
On March 27, 2019, the US Food and Drug Administration (FDA) issued an alert from its Office of Women’s Health announcing that, after more than 20 years of regulatory oversight, the agency is proposing amendments to the existing policy governing mammography services.
Web Exclusives | March 22, 2019
For the second time this month, the FDA has given an approval to Genentech’s PD-L1 inhibitor, Tecentriq.
Web Exclusives | March 15, 2019
On March 8, 2019, the FDA granted accelerated approval to Genentech’s Tecentriq (atezolizumab), in combination with nab-paclitaxel (Abraxane), for the treatment of PD-L1–positive unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). This marks the first time an immunotherapy drug has been granted approval for the treatment of any form of breast cancer.
Web Exclusives | March 8, 2019
Approvals for new delivery methods for Herceptin and Cinvanti, and a new indication for Lonsurf close out the month of February in the FDA’s oncology-related activity.
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