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Roche Receives FDA Approval For Cobas HPV Test For Use ...

(Roche) Apr 21, 2020 - Roche today announced US Food and Drug Administration (FDA) approval for the cobas® HPV test for use on the fully auto...

COVID-19: Impact On Cancer Workforce and Delivery Of Care

(The Lancet Oncology) Apr 20, 2020 - Balancing the risk of coronavirus disease 2019 (COVID-19) for patients with cancer and health-care worker...

The Pandemic’s Hidden Victims: Sick or Dying, but...

(New York Times) Apr 20, 2020 - As the coronavirus overwhelms the health care system, people with other illnesses struggle to find treatment. ...

Featured Content

Zev Wainberg, MD, on the role of pembrolizumab for MSI high CRC patients and its use in therapy

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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Andrew Armstrong, MD, shares impressions of the CARD study investigating cabazitaxel in metastatic castration-resista...

Tanya Dorff, MD, shares thoughts of the optimal sequence of atezolizumab and sip-T in mCRPC

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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...

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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 Part V of Life with Cancer: A Guide to Getting the Best Care (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 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).
May 14	Blueprint Medicines , Ayvakit™ (avapritinib) The company announced on Feb. 6, 2020 that the FDA had extended its PDUFA action date by three months from Feb. 14, 2020 to May 14, 2020 for its NDA seeking accelerated approval of avapritinib for the treatment of adults with fourth-line gastrointestinal stromal tumor (GIST). The FDA cited its request for top-line data from Blueprint Medicines' ongoing phase 3 VOYAGER clinical trial, comparing avapritinib to regorafenib in third- or fourth-line GIST, as the reason for the extension. Blueprint expects to submit the data early in the second quarter of 2020. Ayvakit, a kinase inhibitor, became the first precision therapy FDA approved to treat a genomically defined population of patients with gastrointestinal stromal tumor (GIST) on Jan. 9, 2020. The indication approved by U.S. regulators is for the treatment of adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations. The company also said in its Feb. 6 announcement that the NCCN had updated its Clinical Practice Guidelines in Oncology for soft tissue sarcoma to include avapritinib as a recommended category 2A treatment for unresectable or metastatic GIST with a PDGFRA exon 18 mutation, including PDGFRA D842V mutations, as well as fourth-line GIST. The rating indicates that there is uniform NCCN consensus that the intervention is appropriate. Blueprint has a broad clinical development program in place for avapritinib across multiple lines of GIST treatment, in addition to advanced, smoldering and indolent systemic mastocytosis (SM).
May 15	Clovis Oncology, Rubraca® (rucaparib) Clovis Oncology said on Jan. 15, 2020 that the FDA had accepted the company’s sNDA for Rubraca as monotherapy for adult patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer and granted a Priority Review to the application. The PDUFA action date assigned for an FDA decision is May 15, 2020. The submission is based on data from the Triton clinical program in advanced prostate cancer.
May 15	Bristol-Myers Squibb, Opdivo® (nivolumab) + Yervoy® (ipilimumab) The company said on Jan. 15, 2020 that U.S. regulators had accepted its sBLA for Opdivo in combination with Yervoy for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. The FDA granted the application Priority Review with a PDUFA goal date of May 15, 2020. The application is based on data from part 1 of the phase 3 CheckMate -227 trial evaluating Opdivo plus Yervoy vs. chemotherapy in patients with previously untreated NSCLC. The dual immunotherapy combination demonstrated significant improvement in overall survival versus chemotherapy alone in the trial.
Jun 02	Immunomedics, sacituzumab govitecan (IMMUNO-132) The company said on Apr. 6, 2020 that it was halting its phase 3 confirmatory ASCENT study testing its antibody-drug conjugate, sacituzumab govitecan, in patients with metastatic triple-negative breast cancer (mTNBC) due to "compelling evidence of efficacy." The decision was based on the unanimous recommendation by the independent Data Safety Monitoring Committee (DSMC) during a recent routine review of the trial, the company said. The confirmatory ASCENT study is designed to validate the safety and efficacy data of sacituzumab govitecan observed in a phase 2 study of heavily pretreated patients with the disease. The primary endpoint of the study is progression-free survival, and secondary endpoints include overall survival and objective response rate, among others. The full dataset from ASCENT is expected in the second half of 2020. A BLA resubmission seeking accelerated approval of sacituzumab govitecan for patients with mTNBC who have received at least two prior therapies for metastatic disease is currently under FDA review, with a PDUFA target action date of June 2, 2020. The FDA issued a Complete Response Letter for the initial marketing application in Jan. 2019, citing manufacturing issues. Sacituzumab govitecan was previously granted Breakthrough Therapy Designation in the disease setting.