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Opdivo (nivolumab) Significantly Improves Disease Free-...

(BMS) Sept 24, 2020 - Bristol Myers Squibb today announced that CheckMate -274, a pivotal Phase 3 trial evaluating Opdivo (nivolumab) after su...

FDA Takes Actions to Help Lower U.S. Prescription Drug ...

(FDA.gov) Sept 24, 2020 - Today, the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration took actions to he...

Esmo 2020 Movers – Antibody Drug Conjugates Domin...

(Evaluate Vantage) Sept 24, 2020 - Notable progress with antibody-drug conjugates from Seattle Genetics and Immunomedics drove the biggest Esm...

'Paradigm Shift' in Gastric Junction Cancers With Nivol...

(Medscape Medical News) Sept 23, 2020 - Nivolumab immunotherapy could soon be used in the first-line in gastric or gastroesophageal junction c...

Community Oncology Alliance Issues Position Statement o...

(COA) Sept 24, 2020 - Telehealth is effective substitute for some, but not all and in-person visits for cancer care should continue beyond COV...

Featured Content

Petros Grivas, MD, PhD, summarizes the clinical progress made in prostate cancer from ESMO 2020

Robert Figlin, MD, Steven Spielberg Family Chair in Hematology-Oncology, Cedars-Sinai Medical Center, and Sara Hurvitz, MD, Associate Professor of Medicine, Geffen School of Medicine, UCLA, Medical Director, Jonsson Comprehensive Cancer Center Clinical Research Unit, discuss breast cancer patient types, challenges, and treatment advances.

Immunotherapy is still struggling to gain a foothold in ovarian cancer, renal cell carcinoma and lymphoma. See what experts at the ASCO20 Virtual Education Program had to say about the current immunotherapy paradigms for these specific cancer types.

Key takeaways from a recent SNO Brain Metastases Virtual Conference included how the genetic differences between brain mets and primary tumors point to a more individualized treatment approach, and results from a substudy confirming the major benefit of a new agent for mBC against brain metastases. Delve deeper into some of the latest data on treating pa...

The current public health crisis calls for a more proactive approach and streamlined access to patient support programs that will alleviate the financial burden experienced by both cancer patients and providers. We take a closer look at the problem and its possible solutions.

Podcasts

Breast Cancer - Sara Hurvitz, MD, and Robert Figlin, MD, discuss recent clinical developments in early stage and late stage breast cancer

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Adjuvant Lung Cancer - Roy Herbst, MD, and Robert Figlin, MD, discuss the recent ASCO20 plenary presentation of the A...

06/25/20

Breast Cancer – Nancy Lin, MD, and Robert Figlin, MD, discuss novel agents and recent clinical developments in ...

06/12/20

Non Small Cell Lung Cancer (NSCLC) – Edward Garon, MD, and Robert Figlin, MD, discuss promising agents in devel...

06/11/20

Colon and Rectal Cancer – David Ilson, MD, and Robert Figlin, MD, discuss recent clinical advances in colon and...

06/08/20

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Erika Hamilton, MD, considers the significance of the MonarchE study & the use of abemaciclib

Andrew Zelenetz, MD, discusses the validity and availability of the EZH2 companion diagnostic test

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September 2020 Edition

Immunotherapy is still struggling to gain a foothold in ovarian cancer, renal cell carcinoma and lymphoma. See what experts at the ASCO20 Virtual Education Program had to say about the cu...

September 2020 Edition

Key takeaways from a recent SNO Brain Metastases Virtual Conference included how the genetic differences between brain mets and primary tumors point to a more individualized treatment app...

September 2020 Edition

The current public health crisis calls for a more proactive approach and streamlined access to patient support programs that will alleviate the financial burden experienced by both cancer...

Blog

ASCO 2020 Highlights for Sunday

May 31, 2020

Sunday’s live broadcast of the virtual scientific program of the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting featured late-breaking data fr...

ASCO 2020 Highlights for Saturday

May 30, 2020

The live broadcast of the virtual scientific program of the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting kicked off this morning with highligh...

Sneak Peek at ASCO 2020 Plenary Sessions

May 29, 2020

Ahead of this weekend’s live broadcast of the virtual scientific program of the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting, late-breaking ...

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The Oncology Business Dynamics Learning Platform addresses the need to have a high level of understanding of the non-clinical issues that are influencing the decision making process for hem/oncs today.

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October 3-5, 2020

Coping with Metastatic Triple Negative Breast Cancer: Part I of Life with Metastatic Triple Negative Breast Cancer (CancerCare Connect Education Workshop)

(by phone or via webcast)

October 15-17, 2020

Caregiving for Your Loved One Living with Metastatic Triple Negative Breast Cancer: Part II of Life with Metastatic Triple Negative Breast Cancer (CancerCare Connect Education Workshop)

(by phone or via webcast)

November 3, 2020

OBR Radar

Top 5 Market Moving Events

Date	Company and Product
Nov 16	Bristol-Myers Squibb, lisocabtagene maraleucel (liso-cel) The company provided an update on May 6, 2020 regarding its BLA submission to the FDA for liso-cel and said that the PDUFA action date of Aug. 17, 2020 had been extended by three months to Nov. 16, 2020. The FDA requested additional information following its acceptance of the company's marketing application for liso-cel, which would require additional time for U.S. regulators to review, the company said. BMS previously announced on Feb. 13, 2020 that the FDA had accepted for Priority Review its BLA for lisocabtagene maraleucel (liso-cel), a CD19-directed CAR T-cell product, for the treatment of adults with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies. The BLA is based on the safety and efficacy results from the TRANSCEND NHL 001 trial, a phase 1 trial evaluating liso-cel in 268 patients with R/R large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), high-grade lymphoma, primary mediastinal B-cell lymphoma and Grade 3B follicular lymphoma. That trial is the largest study of CD19-directed CAR T cells to support a BLA to date with results presented at the 2019 ASH annual meeting. Liso-cel has not yet been approved for use in any country.
Sep 30	Mesoblast Ltd., Ryoncil™ (remestemcel-L) The company announced on Apr. 1, 2020 that the FDA had accepted for priority review the BLA filing for Ryoncil, its allogeneic (off-the-shelf) cell therapy for the treatment of children with steroid-refractory acute graft versus host disease (SR-aGVHD). On Aug. 13, 2020 the FDA's ODAC voted 9-1 that the available data supported the efficacy of remestemcel-L in pediatric patients with SR-aGVHD and recommended that the FDA approve the experimental cell therapy. The PDUFA, or target action date, for an FDA decision is Sept. 30, 2020. There are currently no FDA-approved treatments in the U.S. for children under 12 with SR-aGVHD. Mesoblast's lead pipeline candidate, Ryoncil is comprised of culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor, and is administered to patients in a series of intravenous infusions. If approved, the company will make the therapy immediately available in the U.S.
Oct 30	Merck , Keytruda® (pembrolizumab) The company said on July 8, 2020 that the FDA had accepted and granted priority review to the sBLA for Keytruda as monotherapy for adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). The application is based on data from the pivotal phase 3 KEYNOTE-204 trial comparing Keytruda to brentuximab vedotin (BV), a current standard of care in this patient population. In the trial, Keytruda demonstrated a significant improvement in progression-free survival (PFS) compared to BV. The FDA has set a PDUFA, or target action date of Oct. 30, 2020 for a decision on the new indication. KEYNOTE-204 is also serving as the confirmatory trial for the Keytruda's accelerated approval hematology indications.
Nov 28	Merck , Keytruda® (pembrolizumab) Merck announced on July 30, 2020 that the FDA had accepted and granted priority review to a new sBLA seeking accelerated approval for pembrolizumab in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10). The application for metastatic TNBC is based on the phase 3 KEYNOTE-355 trial. In that trial, pembro plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with chemotherapy alone in patients whose tumors expressed PD-L1 at CPS ≥10 who comprised about 38% of patients enrolled in the study. These data were presented at ASCO 2020. The trial will continue without changes to evaluate the other dual primary endpoint of overall survival (OS). The submission marks one of the first U.S. marketing applications for Keytruda in breast cancer. The FDA has set a PDUFA, or target action, date of Nov. 28, 2020.
Nov 30	Y-mAbs Therapeutics, Danyelza™ (naxitamab) Y-mAbs announced on June 2, 2020 that the Biologics License Application (BLA) for Danyelza for the treatment of relapsed/refractory high-risk neuroblastoma had been accepted for priority review by the FDA. The Agency set a target action date of Nov. 30, 2020. The FDA is not currently planning to hold an advisory committee meeting to discuss the application. The BLA submission is based on the safety and efficacy results of the pivotal phase 2 studies 201 and 12-230, which Y-mAbs expects to present later this year. Danyelza, one of the company's two pivotal-stage product candidates, is a new generation anti-GD2 monoclonal antibody (mAb) targeting tumors that express GD2 and was developed by Memorial Sloan Kettering researchers.