Industry News

FDA Approves Lorlatinib for ALK+ Metastatic NSCLC

On November 2, the FDA granted accelerated approval to lorlatinib (Lorbrena, Pfizer Inc.) for patients with ALK+ metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on crizotinib and at least one other ALK inhibitor for metastatic disease or whose disease has progressed on alectinib or ceritinib as the first ALK inhibitor therapy for metastatic disease.

Read the full FDA press release here.

Posted 11/5/2018

FDA Approves Kyprolis Once-Weekly Dosing Option for Multiple Myeloma
On October 1, the FDA approved the supplemental New Drug Application (sNDA) to expand the Prescribing Information for Kyprolis (carfilzomib) to include a once-weekly dosing option in combination with dexamethasone (once-weekly Kd70) for patients with relapsed or refractory multiple myeloma.

Read the full Amgen press release here.

Posted 10/31/2018

FDA Approves Pembrolizumab for First-Line Treatment of Metastatic Squamous NSCLC
On October 30, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck & Co., Inc.) in combination with carboplatin and either paclitaxel or nab-paclitaxel as first-line treatment of metastatic squamous non-small cell lung cancer (NSCLC).

Read the full FDA press release here.

Posted 10/31/2018

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

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 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 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