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FDA Approves Pill For Aggressive Breast Cancer That's S...

(ABC News/Associated Press) Apr 17, 2020 - U.S. regulators have approved a new drug for an aggressive type of breast cancer that’s spread in...

FDA Approves First Targeted Treatment for Patients with...

(FDA.gov) Apr 17, 2020 - Today, the U.S. Food and Drug Administration granted accelerated approval to Pemazyre (pemigatinib), the first treatm...

Bristol Myers Squibb and Exelixis Announce Positive Top...

(BMS) Apr 20, 2020 - Study met primary endpoint of significantly improving progression-free survival, and secondary endpoints of overall survi...

Bristol Myers Squibb Announces Positive Topline Result ...

(BMS) Apr 20, 2020 - Opdivo plus Yervoy prolonged survival compared to chemotherapy at interim analysis in CheckMate -743. Malignant pleur...

Featured Content

David H Ilson, MD, on the JAVELIN 100 study and the need for quick responses and immunotherapy in GE

Robert Figlin, MD, Steven Spielberg Family Chair in Hematology-Oncology, Cedars-Sinai Medical Center, and Tian Zhang, MD, Assistant Professor of Medicine, Duke University School of Medicine, discuss the progress in RCC presented at ASCO GU '20

Dr. Debra Patt of Texas Oncology and Dr. Samuel Silver of the University of Michigan Medical Center discuss how the fallout from COVID-19 has adversely impacted patients with cancer and provide insight as to what oncology practices are doing to keep their patients and staff safe during these uncertain times.

Cancer doesn’t have a pause button. In an op-ed, COA’s executive director Ted Okon talks about how CMS’ expansion of telehealth services is a lifeline for cancer patients and the community oncologists who treat them during this unprecedented public health crisis.

The FDA's principal deputy commissioner, Dr. Amy Abernethy, an internationally recognized clinical data expert and researcher, sat down with OBR to tell us about some of the various technology-directed initiatives covering digital tools, telemedicine, real world evidence and AI that she oversees, and how oncology factors into them.

Podcasts

Renal Cell Carcinoma (RCC) – Tian Zhang, MD, and Robert Figlin, MD, discuss recent clinical advances in RCC from ASCO GU

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Prostate Cancer – Daniel Petrylak, MD, and Robert Figlin, MD, discuss recent clinical advances in prostate canc...

03/02/20

Colorectal Cancer – Zev Wainberg MD, and Robert Figlin, MD, discuss recent clinical advances in colorectal canc...

02/12/20

Mantle Cell Lymphoma (MCL) – Michael Wang MD, and Robert Figlin, MD, discuss recent clinical advances in mantle...

02/03/20

Chronic Lymphocytic Leukemia (CLL) – Lori Leslie MD, and Robert Figlin, MD, discuss clinical highlights in the ...

01/10/20

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Rana McKay, MD discusses Checkmate 214 investigating nivolumab + ipilimumab in 1st line RCC patients

Tilak Sundaresan, MD, regarding the results of the TAPUR study and its importance to physicians

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April 2020 Edition

Dr. Debra Patt of Texas Oncology and Dr. Samuel Silver of the University of Michigan Medical Center discuss how the fallout from COVID-19 has adversely impacted patients with cancer and p...

April 2020 Edition

Cancer doesn’t have a pause button. In an op-ed, COA’s executive director Ted Okon talks about how CMS’ expansion of telehealth services is a lifeline for cancer patients and the c...

April 2020 Edition

The FDA's principal deputy commissioner, Dr. Amy Abernethy, an internationally recognized clinical data expert and researcher, sat down with OBR to tell us about some of the various techn...

Blog

New Telehealth Policies Ensuring Cancer Patients Aren&r...

Apr 07, 2020

I don’t have to tell anyone that the novel coronavirus has caused an unprecedented global crisis. However, with attention rightfully so on COVID-19, and the str...

Dean's Digest - ASCO GU 2020

Feb 19, 2020

Major themes which emerged from ASCO GU 2020 included a plethora of studies utilizing various permutations of targeted therapies along with immunotherapy and/or c...

Dean's Digest - ASCO GI 2020

Jan 28, 2020

ASCO GI 2020 was held in San Francisco January 23-25. Numerous studies involving Phase 1/2 evaluations of new drugs in gastrointestinal (GI) malignancies were rep...

OBR Tools

Stemming from the user preference that you set, stay informed and increase your productivity via 27/7 web based access to Ontellitrac and a customized email alert system summarizing the most recent oncology-specific information available.

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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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April 22 - 25, 2020

SWOG Spring 2020 Virtual Group Meeting

[Virtual Group Meeting]

April 22, 2020

For Caregivers: Care Coordination for Your Loved One Living with Cancer and Other Health Problems (CancerCare Connect® Education Workshop)

[by phone or online via webcast]

April 23 - 24, 2020

Understanding the Role of Immunotherapy in Treating Cancer Part I of New Trends in Immunotherapy (CancerCare Connect® Education Workshops)

(by phone or via webcast)

April 29, 2020

Triple Negative Breast Cancer and African American Women (CancerCare Connect® Education Workshops)

(by phone or via webcast)

April 30, 2020

Current Perspectives on the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) Part II of Life with Chronic Lymphocytic Leukemia (CLL) (CancerCare Connect® Education Workshops)

(by phone or via webcast)

April 30, 2020

Life with Graft vs. Host Disease (GVHD) Post Allogeneic Stem Cell or Bone Marrow Transplantation: New Treatment Approaches (CancerCare Connect® Education Workshops)

(by phone or via webcast)

May 2 - 3, 2020

Memorial Sloan Kettering 5th Annual MSK Symposium on Lymphoma [CANCELLED; POSTPONED TIL 2021]

New York, NY

May 4, 2020

New Perspectives in the Treatment of Advanced Skin Cancer: Advanced Basal Cell and Squamous Cell Cancers Part I of Life with Advanced Skin Cancer (CancerCare Connect® Education Workshops)

(by phone or via webcast)

May 4, 2020

Triple Negative Breast Cancer and Fear of Recurrence (CancerCare Connect® Education Workshops)

(by phone or via webcast)

May 6, 2020

Managing the Side Effects of Immunotherapy Part II of New Trends in Immunotherapy (CancerCare Connect® Education Workshops)

(by phone or via webcast)

May 8, 2020

Emerging Treatments for Metastatic Melanoma Part II of Life with Advanced Skin Cancer (CancerCare Connect® Education Workshops)

(by phone or via webcast)

May 11, 2020

Update on CAR-T Cell Therapy (CancerCare Connect® Education Workshops)

(by phone or via webcast)

May 11, 2020

Treatment Update on Liver Cancer (CancerCare Connect® Education Workshops)

(by phone or via webcast)

May 13, 2020

What’s New in the Treatment of Bladder Cancer Part I of Life with Bladder Cancer (CancerCare Connect® Education Workshops)

(by phone or via webcast)

May 14-16, 2020

ISNS 2020 (International Sentinel Node Society’s Biennial Meeting in collaboration with the Society of Surgical Oncology)

Houson, TX

May 15 - 16, 2020

2020 MSK Cardio-Oncology Symposium [CANCELLED; POSTPONED TIL 2021]

New York, NY

May 21, 2020

Coping with the Stresses of Caregiving When Your Loved One Has Chronic Lymphocytic Leukemia (CLL) (CancerCare Connect® Education Workshops)

(by phone or via webcast)

May 23 - 24, 2020

ESMO Breast Cancer Virtual Meeting

[Virtual Format]

May 27, 2020

For Caregivers: Practical Tips to Cope with Your Loved One’s Bladder Cancer Part II of Life with Bladder Cancer (CancerCare Connect® Education Workshops)

(by phone or via webcast)

May 29 - June 2, 2020

2020 ASCO Annual Meeting [VIRTUAL FORMAT]

[Virtual Format]

June 11 - 14, 2020

25th EHA Congress (European Hematology Association) [VIRTUAL FORMAT]

Frankfurt, Germany

June 27, 2020

Memorial Sloan Kettering 2nd Annual Palliative Care Symposium for Advanced Practice Providers [CANCELLED; POSTPOSED TIL 2021]

New York, NY

June 27 - 28, 2020

OBR Radar

Top 5 Market Moving Events

Date	Company and Product
Apr 17	Seattle Genetics, Tukysa™ (tucatinib) tablets On Apr. 17, 2020 the FDA approved Seattle Genetics' tucatinib (brand name Tukysa) in combination with trastuzumab and capecitabine for patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with and without brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. U.S. regulators approved the new breast cancer therapy four months ahead of the PDUFA action date of Aug. 20, 2020 under the Real-Time Oncology Review (RTOR) pilot program. The NDA is part of Project Orbis, a new initiative of the FDA Oncology Center of Excellence providing a framework for concurrent submission and review of cancer drugs among participating international health authorities. Tucatinib is an oral, small molecule tyrosine kinase inhibitor (TKI) that is highly selective for HER2. The filing is based on results from the pivotal HER2CLIMB trial.
Apr 17	Incyte Corp., Pemazyre™ (pemigatinib) The FDA approved Incyte’s Pemazyre on Apr. 17, 2020 for adult patients with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. Pemazyre is the first and only FDA-approved treatment for the indication, which received an accelerated approval based on overall response rate and duration of response (DOR). Cholangiocarcinoma is a rare cancer that forms in the bile duct.
Apr 20	Bristol Myer Squibb / Exelixis , Opdivo® (nivolumab) + Cabometyx® (cabozantinib) The companies announced on Apr. 20, 2020 positive topline results from the pivotal phase 3 CheckMate -9ER trial evaluating Opdivo in combination with Cabometyx compared to sunitinib in previously untreated advanced or metastatic renal cell carcinoma (RCC). The study met its primary endpoint of significantly improving progression-free survival (PFS) at the final analysis, as well as the secondary endpoints of overall survival (OS) at a pre-specified interim analysis, and objective response rate (ORR), versus sunitinib. The companies said they plan to submit detailed results of CheckMate -9ER for presentation at an upcoming medical meeting. If approved, the company's lead investigator said that the combination could become an important new first-line treatment option for patients with metastatic kidney cancer.
Apr 20	Bristol Myers Squibb , Opdivo® (nivolumab) + Yervoy® (ipilimumab) The company said on Apr. 20, 2020 that the combination of Opdivo plus Yervoy in previously untreated malignant pleural mesothelioma (MPM) prolonged survival compared to chemotherapy in the pivotal CheckMate -743 trial. Based on a pre-specified interim analysis conducted by the independent Data Monitoring Committee, the combination of the two immunotherapies resulted in a statistically significant and clinically meaningful improvement in overall survival (OS) compared to chemotherapy (pemetrexed and cisplatin or carboplatin). Malignant pleural mesothelioma is a rare, aggressive cancer with limited treatment options. BMS said it would present the trial's results at a future medical meeting, and would discuss the clinical data with health authorities.
Apr 30	Blueprint Medicines , Ayvakit™ (avapritinib) Top-line data from the ongoing phase 3 VOYAGER trial (NCT03465722), comparing avapritinib to regorafenib in third- or fourth-line GIST, is due from the company early in the second quarter of 2020. The trial results will inform the FDA's pending action on Blueprint Medicines' NDA for avapritinib in fourth-line GIST. The FDA is due to make an approval decision on the therapy in that indication by May 14, 2020. (See our Blueprint Radar entry for May 14, 2020 for more).