Jason M. Broderick

Articles

Almonertinib Approved in China for EGFR T79M+ NSCLC

March 19th 2020

The Chinese National Medical Products Administration has approved almonertinib (Ameile; HS-10296) for the treatment of patients with EGFR T790M mutation–positive non–small cell lung cancer who have progressed on or after other EGFR TKI therapy.

FDA Grants ALPN-101 Orphan Drug Designations in GVHD

March 18th 2020

The FDA has granted 2 Orphan Drug Designations to ALPN-101 for the prevention and treatment of acute graft-versus-host-disease.

Durvalumab/Chemo OS Benefit Sustained in ES-SCLC, But Durvalumab/Tremelimumab Regimen Falls Short

March 17th 2020

Combining durvalumab with standard frontline chemotherapies showed a sustained overall survival benefit in patients with extensive-stage small cell lung cancer, but a regimen of durvalumab, chemotherapy, and tremelimumab did not boost OS.

Case Series Shows Feasibility of Haploidentical Transplant in High-Risk Myelofibrosis

March 17th 2020

Haploidentical allogeneic stem cell transplant is a viable treatment option for patients with myelofibrosis who have a higher risk for posttransplant complications and mortality.

Niraparib Takes Step Toward Chinese Approval for Frontline Maintenance in Ovarian Cancer

March 16th 2020

The China National Medical Products Administration has accepted a supplemental New Drug Application for niraparib for use as a frontline maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy.

Frontline Avelumab Falls Short in Phase III Head and Neck Cancer Study

March 13th 2020

The phase III JAVELIN Head and Neck 100 trial has been terminated after an interim analysis showed that the addition of avelumab to standard-of-care chemoradiotherapy was unlikely to lead to a statistically significant improvement in progression-free survival in patients with untreated locally advanced squamous cell carcinoma of the head and neck.

FDA Grants Balstilimab/Zalifrelimab Dual Immunotherapy Fast Track Designation in Cervical Cancer

March 13th 2020

The FDA has granted a Fast Track designation to the combination of the PD-1 inhibitor balstilimab and the CTLA-inhibitor zalifrelimab for the treatment of patients with relapsed or refractory metastatic cervical cancer.

FDA Approves Cytology Test to Enhance Cervical Cancer Prevention

March 11th 2020

The FDA has approved the CINtec PLUS Cytology test as the first biomarker-based triage test for women whose primary cervical cancer screening results are positive for the human papillomavirus using the cobas 4800 HPV Test.

Adjuvant Chemotherapy Shows Strong Benefit in Upper Tract Urothelial Carcinoma

March 7th 2020

Adjuvant platinum-based chemotherapy reduced the risk of disease recurrence or death by 55% in patients with upper tract urothelial carcinoma, according to findings from the phase III POUT trial that have now been published in The Lancet.

Larotrectinib Data Further Demonstrate Strong Efficacy in TRK+ Tumors

March 6th 2020

Larotrectinib continued to show strong tumor-agnostic efficacy in patients with TRK fusion–positive cancers, according to results from an integrated analysis of 3 clinical trials.

FDA Grants Umbralisib Orphan Drug Status in Follicular Lymphoma

March 6th 2020

The FDA has granted an orphan drug designation to umbralisib for the treatment of patients with follicular lymphoma.

Mayo Researchers: Change NCCN Criteria to Expand Genetic Testing in Breast Cancer

March 6th 2020

Researchers at the Mayo Clinic maintain that all women aged 65 or under with a breast cancer diagnosis should receive germline genetic testing to identify harmful mutations that increase their risk of developing secondary cancers.

Antidepressant Shows Antitumor Potential in Prostate Cancer

March 4th 2020

The antidepressant phenelzine showed antitumor activity in patients with biochemical recurrent castrate-sensitive prostate cancer.

Brigatinib Nears EU Approval for Frontline ALK+ NSCLC

March 2nd 2020

The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion for a Marketing Authorization Application for brigatinib for the first-line treatment of patients with ALK-positive metastatic non–small cell lung cancer

Venetoclax Combo Misses OS Endpoint in Phase III Frontline AML Trial

March 2nd 2020

Combining venetoclax with low-dose cytarabine (LDAC) did not lead to a statistically significant improvement in overall survival compared with LDAC alone in newly-diagnosed patients with acute myeloid leukemia who are ineligible for intensive chemotherapy, according to findings from the phase III VIALE-C (M16-043) trial.

Deep Data Dive Needed for Upfront Treatment Selection in iNHL

February 29th 2020

At the 24th Annual International Congress on Hematologic Malignancies®, Sonali M. Smith, MD, detailed the critical clinical trial findings currently informing treatment selection in the frontline indolent non-Hodgkin lymphoma paradigm.

FDA Accepts BLA for Subcutaneous Fixed-Dose Pertuzumab/Trastuzumab in HER2+ Breast Cancer

February 25th 2020

The FDA has accepted a Biologics License Application for a fixed-dose combination of pertuzumab and trastuzumab with hyaluronidase, administered by subcutaneous injection in combination with intravenous chemotherapy, for the treatment of eligible patients with HER2-positive breast cancer.

FDA Accepts Niraparib Application for Frontline Maintenance in Ovarian Cancer

February 24th 2020

The FDA has accepted a supplemental New Drug Application for niraparib for use as a frontline maintenance treatment for women with advanced ovarian cancer who responded to platinum-based chemotherapy regardless of biomarker status.

FDA Grants Brigatinib Priority Review for Frontline ALK+ NSCLC

February 24th 2020

The FDA has granted a priority review designation to a supplemental New Drug Application for brigatinib for the first-line treatment of patients with ALK-positive metastatic non–small cell lung cancer.

Nivolumab Approved in Japan for Esophageal Cancer

February 21st 2020

The Japanese Ministry of Health, Labor and Welfare has approved nivolumab for the treatment of patients with unresectable advanced or recurrent esophageal cancer that has progressed following chemotherapy.