Industry News

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 her e.

Posted 8/17/2018

FDA Approves Lenvatinib for Unresectable Hepatocellular Carcinoma

On August 16, 2018, the Food and Drug Administration approved lenvatinib (Lenvima, Eisai Inc.) for first-line treatment of patients with unresectable hepatocellular carcinoma (HCC). Approval was based on an international, multicenter, randomized, open-label, non-inferiority trial conducted in 954 patients with previously untreated, metastatic or unresectable HCC. The trial demonstrated that lenvatinib was non-inferior but not statistically superior to sorafenib for overall survival.

Read the full FDA press release here.

Posted 8/17/2018

FDA Approves Filgrastim Biosimilar for AML
On July 20, the Food and Drug Administration (FDA) approved filgrastim-aafi (Nivestym, Pfizer Inc.) for the treatment of chemotherapy-induced febrile neutropenia, acute myeloid leukemia (AML), patients with cancer receiving bone marrow transplant, peripheral blood progenitor cell collection and engraftment, and severe chronic neutropenia. This is the second approved biosimilar for filgrastim (Neupogen, Amgen) following the approval of filgrastim-sndz (Zarxio, Sandoz) in 2015.

Read the Pfizer corporate press release here.

Posted 7/23/2018

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 Enzalutamide for Castration-resistant Prostate Cancer

On July 13, 2018, the U.S. Food and Drug Administration (FDA) approved enzalutamide (Xtandi, Astellas Pharma US, Inc.), for patients with castration-resistant prostate cancer (CRPC).

This approval broadens the indicated patient population to include patients with both non-metastatic CRPC (NM-CRPC) and metastatic CRPC. Enzalutamide was previously approved for the treatment of patients with metastatic CRPC.

Read FDA announcement.

Posted 7/16/2018

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