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  • Daratumumab is an anti-CD38 monoclonal antibody that has transformed the landscape of treatment both for transplant-eligible and -ineligible patients with newly diagnosed multiple myeloma. Addressing important ongoing questions, such as when to de-escalate therapy, will be an important step forward in delivering patient-centred care for those with newly diagnosed multiple myeloma.

    • Ghulam Rehman Mohyuddin
    • Hira Mian
    Comment
  • Legislators in the USA have been discussing reforms to reduce the high cost of brand-name drugs, which are much higher in the USA than in other industrialized countries. One solution is to actively negotiate prices based on drugs’ clinical benefits. We discuss two important complexities from such an approach: drugs that have been approved for multiple indications and as part of a combination regimen.

    • Kerstin N. Vokinger
    • Aaron S. Kesselheim
    Comment
  • Recent FDA draft guidance for sponsors of oncology clinical trials encourages enrolment of patients with incurable cancer and no potential for prolonged and/or near-normal survival, regardless of whether they have received existing treatment options. This guidance constitutes a substantial departure from current standards, with potentially profound implications for trial participants as well as drug regulation and reimbursement.

    • Mark P. Lythgoe
    • Vinay Prasad
    Comment
  • The treatments oncologists deliver are generally based on evidence from large randomized controlled trials, consistent with practice guidelines, and congruent with the treatments selected by our peers. In this Comment, we use two scenarios to highlight the discomfort clinicians might feel when they are outliers from the guideline-recommended standard of care.

    • Christopher M. Booth
    • Aaron M. Goodman
    Comment
  • Data from several trials support the efficacy of first-line tyrosine-kinase inhibitors combined with immune-checkpoint inhibitors (ICIs) in metastatic renal cell carcinoma. However, whether combining these drugs is preferable to using them sequentially remains unclear. Here, we assess the implications for patients and payers of limited access to second-line ICIs in the control arms of trials.

    • Garth W. Strohbehn
    • Daniel A. Goldstein
    Comment
  • Two recent drug approvals for metastatic breast cancer highlight that the evidence standards required to support FDA approval seem to be decreasing. These two drugs not only failed to improve overall survival, but their effects on progression-free survival were also astonishingly low; in one case, the treatment delayed progression by only 3 days.

    • Bishal Gyawali
    • Aaron S. Kesselheim
    Comment
  • Precision oncology is predicated on information derived from high-quality tissue samples. Despite almost half of all patients with cancer receiving radiotherapy, samples from these patients are much less commonly available for use in biomarker studies. Biobanks that include material from radiotherapy studies do exist; the challenge is increasing their visibility and accessibility to researchers to continue our efforts to improve outcomes for our patients.

    • Duncan C. Gilbert
    • Valerie Speirs
    Comment
  • The coronavirus disease 2019 (COVID-19) pandemic has disrupted health care worldwide. Patients with cancer seem to be particularly susceptible to morbidities and mortality from this novel disease. No COVID-19-specific therapy currently seems to offer a survival benefit to this unique patient population. Furthermore, the global effects on routine cancer care will likely be felt for decades to come.

    • Leora Horn
    • Marina Garassino
    Comment
  • Single-arm phase II trials can provide compelling results that facilitate the approval of a new therapy. Designing and interpreting single-arm studies based on four principles — instinct, comparative analysis, statistical soundness and like-for-like comparisons — can provide indications as to which drugs are most likely to provide improved therapeutic options for patients.

    • Robert H. Glassman
    • Grace Kim
    • Marc J. Kahn
    Comment
  • Zanubrutinib was recently granted expedited approval by the USA and Chinese drug regulatory authorities for the treatment of mantle cell lymphoma, thus becoming the first investigational new drug discovered in China to achieve simultaneous development in both countries. Here, we provide an overview of the regulatory processes and considerations of the two health authorities and discuss the pathways of concurrent review and approval.

    • Guanqiao Li
    • Xiaozhen Liu
    • Xiaoyuan Chen
    Comment
  • Early published data on COVID-19 in patients with cancer are being referenced in clinical guidelines, despite methodological flaws that limit the quality of much of this evidence. In the next phase of research in this area, we argue that the quality of observational evidence should be prioritized over speed of publication.

    • Andrew G. Robinson
    • Bishal Gyawali
    • Gerald Evans
    Comment
  • The coronavirus disease 19 (COVID-19) pandemic has become the focus of attention worldwide, and herein we seek to highlight the potential problem of ‘collateral mortality’ from delayed or deferred treatments in patients with cancer. We propose potential solutions to ensure continuity of care in the field of surgical oncology.

    • Ker-Kan Tan
    • Brendan J. Moran
    • Michael J. Solomon
    Comment
  • Radiotherapy can be safely delivered during the coronavirus disease 2019 (COVID-19) pandemic, often through use of hypofractionated regimens, which minimize the number of visits to treatment centres while also avoiding potentially detrimental delays in the delivery of cancer care.

    • Himanshu Nagar
    • Silvia C. Formenti
    Comment
  • Health-care services are rapidly transforming their organization and workforce in response to the coronavirus disease 2019 (COVID-19) pandemic. These changes, and a desire to mitigate infection risk, are having profound effects on other vital aspects of care, including the care of patients with cancer. Difficult decisions are being made regarding the prioritization of both active treatments and palliative care, despite limited evidence that cancer is an independent risk factor for infection and mortality.

    • James Spicer
    • Charlotte Chamberlain
    • Sophie Papa
    Comment
  • Informative censoring occurs when progression-free survival is the primary end point of a randomized clinical trial and unequal patient dropout is observed between treatment arms owing to poorer tolerance of experimental treatment. Herein we discuss how informative censoring in the experimental arm before criteria for disease progression are met causes bias towards a positive result.

    • Arnoud J. Templeton
    • Eitan Amir
    • Ian F. Tannock
    Comment
  • During the COVID-19 global pandemic, the cancer community faces many difficult questions. We will first discuss safety considerations for patients with cancer requiring treatment in SARS-CoV-2 endemic areas. We will then discuss a general framework for prioritizing cancer care, emphasizing the precautionary principle in decision making.

    • Timothy P. Hanna
    • Gerald A. Evans
    • Christopher M. Booth
    Comment
  • The FDA has demonstrated a willingness to expedite access to new cancer medicines by using real-world evidence to support regulatory drug approval. In this article, we explore three recent examples of such approvals and the lessons that can be learned from this collective experience.

    • Michael J. Raphael
    • Bishal Gyawali
    • Christopher M. Booth
    Comment
  • In 2019, the FDA Oncology Center of Excellence (OCE) approved 11 new drugs and biologic agents, 30 supplemental drug and biologic applications, and four biosimilar applications in oncology. These included two landmark approvals involving collaboration among international regulators as part of OCE Project Orbis, as well as the approval of three novel antibody–drug conjugates.

    • Harpreet Singh
    • Gideon Blumenthal
    • Richard Pazdur
    Comment