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Industry News Archive

  • FDA Approves Talazoparib for gBRCAm HER2- Breast Cancer

    On October 16, the U.S. Food and Drug Administration approved talazoparib (Talzenna, Pfizer Inc.) for the treatment of patients with deleterious or suspected germline BRCA-mutated (gBRCAm), HER2 negative locally advanced or metastatic breast cancer. Patients must be selected for therapy based on the use of the FDA-approved companion diagnostic BRACAnalysis CDx (Myriad Genetics, Inc.).

    Read the full FDA press release here.

    Posted 10/16/18


  • FDA Expands Approval of HPV Vaccine to People Aged 27 to 45

    On October 5, the U.S. Food and Drug Administration expanded the approved use of Gardasil 9 (Human Papillomavirus [HPV] 9-valent Vaccine, Recombinant, Merck & Co.) to include individuals aged 27 through 45 years. Gardasil 9 prevents certain cancers and diseases caused by nine types of HPV. Gardasil 9 was previously approved for individuals aged 9 through 26 years.

    Read the full FDA press release here.

    Posted 10/8/2018


  • Imfinzi Demonstrates Overall Survival Benefit in Stage III Lung Cancer

    AstraZeneca and MedImmune, its global biologics research and development arm, have presented data on overall survival (OS) in the Phase III PACIFIC trial of Imfinzi (durvalumab) during the Presidential Symposium of the IASLC 19th World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Toronto, Canada. Results were published simultaneously in the New England Journal of Medicine.

    Results from the Phase III PACIFIC trial in patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease had not progressed following chemoradiation showed that Imfinzi significantly improved OS, the second primary endpoint of the trial, compared to placebo regardless of PD-L1 expression, reducing the risk of death by 32%.

    Read the full corporate press release here.

    Posted 9/28/18



  • FDA Approves Dacomitinib for Metastatic NSCLC

    On September 27, the Food and Drug Administration approved dacomitinib tablets (Vizimpro, Pfizer Inc.) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletion or exon 21 L858R substitution mutations as detected by an FDA-approved test.

    Read the full FDA press release here.

    Posted 9/28/18


  • FDA Approves New Treatment for Hairy Cell Leukemia

    On September 13, the Food and Drug Administration approved moxetumomab pasudotox-tdfk (Lumoxiti, AstraZeneca) injection for intravenous use for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. Lumoxiti is a CD22-directed cytotoxin and is the first of this type of treatment for patients with HCL.

    Read the full FDA press release here.

    Posted 9/13/2018


  • FDA Approves Ibrutinib Plus Rituximab for Rare Blood Cancer

    On August 27, AbbVie announced that the FDA has approved ibrutinib (Imbruvica) (Pharmacyclics, LLC) plus rituximab for the treatment of adult patients with Waldenström's macroglobulinemia (WM), a rare and incurable type of non-Hodgkin's lymphoma (NHL). This approval represents the first and only chemotherapy-free combination treatment specifically indicated for the disease.

    Read the full AbbVie corporate press release here.

    Posted 8/27/2018


  • FDA Approves Pembrolizumab + Chemotherapy for NSqNSCLC

    On August 17, 2018, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co., Inc.) in combination with pemetrexed and platinum as first-line treatment of patients with metastatic, non-squamous non-small cell lung cancer (NSqNSCLC), with no EGFR or ALK genomic tumor aberrations.

    Pembrolizumab was previously granted accelerated approval for this indication in May 2017 based on improvements in overall response rate and progression-free survival for patients randomized to pembrolizumab administered with pemetrexed and carboplatin as compared with pemetrexed and carboplatin alone in the KEYNOTE-021 study. This approval represents fulfillment of a postmarketing commitment demonstrating the clinical benefit of this product.

    Read the full FDA announcement here.

    Posted 8/20/2018



  • FDA Approves Nivolumab for Previously Treated SCLC Patients

    On August 17, the U.S. Food and Drug Administration (FDA) approved nivolumab (Opdivo, Bristol-Myers Squibb Co.) for patients with metastatic small cell lung cancer (SCLC) whose cancer has progressed after platinum-based chemotherapy and at least one other line of therapy. Approval for this indication has been granted under accelerated approval based on overall response rate (ORR) and duration of response (DOR).

    Read the BMS press release here.
    Read the FDA announcement here.

    Posted 8/17/2018


  • FDA Approves Ribociclib in Combination for Advanced, Metastatic Breast Cancer

    On July 18, the Food and Drug Administration approved ribociclib (Kisqali, Novartis Pharmaceuticals Corp.) in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy.

    The FDA also approved ribociclib in combination with fulvestrant for the treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy.

    Read the full FDA press release here.

    Posted 7/18/18


  • FDA Approves Nivolumab Plus Ipilimumab for Metastatic Colorectal Cancer

    On July 11, the Food and Drug Administration (FDA) approved nivolumab (Opdivo, Bristol-Myers Squibb) plus Yervoy (ipilimumab, Bristol-Myers Squibb) for the treatment of adult and pediatric patients 12 years and older with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

    Read the full Bristol-Myers Squibb press release here.

    Posted 7/11/2018



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