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Industry News Archive

  • FDA Approves Biosimilar Trastuzumab-anns for All Approved Herceptin Indications

    On June 13, 2019, Amgen and Allergan plc announced the U.S. Food and Drug Administration (FDA) has approved Kanjinti (trastuzumab-anns) for all approved indications of the reference product, Herceptin® (trastuzumab):  for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.

    Read corporate press release.

    Posted 6/14/2019


  • FDA Approves First-Line Pembrolizumab for Metastatic or Unresectable HNSCC

    On June 10, 2019, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda, Merck) for the first-line treatment of patients with metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC).

    Pembrolizumab was approved for use in combination with platinum and fluorouracil (FU) for all patients and as a single agent for patients whose tumors express PD‑L1 (Combined Positive Score [CPS] ≥1) as determined by an FDA‑approved test. The FDA also expanded the intended use for the PD-L1 IHC 22C3 pharmDx kit to include use as a companion diagnostic device for selecting patients with HNSCC for treatment with pembrolizumab as a single agent.

    Read the FDA announcement.

    Posted 6/11/2019


  • FDA Approves Lenalidomide in Combination for Follicular and Marginal Zone Lymphoma

    On May 28, 2019, the U.S. Food and Drug Administration (FDA) approved lenalidomide (Revlimid, Celgene Corp.) in combination with a rituximab product for previously treated follicular lymphoma (FL) and previously treated marginal zone lymphoma (MZL).

    Read FDA announcement.

    Posted 5/28/2019


  • FDA Approves Alpelisib for Metastatic Breast Cancer

    On May 24, 2019, the U.S. Food and Drug Administration (FDA) approved alpelisib (Piqray, Novartis Pharmaceuticals Corporation) in combination with fulvestrant for postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cancer as detected by an FDA-approved test following progression on or after an endocrine-based regimen.

    Read FDA announcement
    .

    Posted 5/28/2019


  • FDA Approves Ruxolitinib for Acute Graft-Versus-Host Disease

    On May 24, Incyte Corporation announced that the U.S. Food and Drug Administration (FDA) has approved ruxolitinib (Jakafi) for the treatment of steroid-refractory acute graft-versus-host disease (aGVHD) for adults and pediatric patients ≥12 years of age. It is the first and only FDA-approved treatment for this indication.

    Read the Incyte press release here.

    Posted 5/24/2019


  • FDA Approves Venetoclax Plus Obinutuzumab for CLL and SLL

    On May 15, AbbVie Inc. and Genentech Inc. announced that the U.S. Food and Drug Administration (FDA) has approved venetoclax (Venclexta) in combination with obinutuzumab (Gazyva) for previously untreated patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The FDA had previously granted Breakthrough Therapy designation to this chemotherapy-free combination.

    Read the Genentech press release
    .

    Posted 5/15/2019


  • FDA Approves Avelumab Plus Axitinib for Advanced RCC

    On May 14, Pfizer Inc. announced that the FDA has approved avelumab (Bavencio) plus axitinib (Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). A Phase III study showed that the combination significantly lowered risk of disease progression or death by 31 percent and extended progression-free survival by 5.4 months for patients with advanced RCC compared with sunitinib.

    Read the Pfizer press release.

    Posted 5/15/2019



  • FDA Approves Ramucirumab for HCC

    On May 10, the U.S. Food and Drug Administration (FDA) approved ramucirumab (Cyramza, Eli Lilly and Company) as a single agent for hepatocellular carcinoma (HCC) in patients who have an alpha fetoprotein (AFP) of ≥ 400 ng/mL and have been previously treated with sorafenib.

    Read the FDA press release here.

    Posted 5/10/2019


  • FDA Approves Pembrolizumab + Axitinib for Advanced Renal Cell Carcinoma

    On April 19, the FDA approved pembrolizumab (Keytruda, Merck & Co. Inc.) plus axitinib (Inlyta, Pfizer Inc.) for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

    Read the full FDA press release here.

    Posted 4/22/2019


  • FDA Approves Erdafitinib for Metastatic Urothelial Carcinoma

    On April 12, the Food and Drug Administration granted accelerated approval to erdafitinib (Balversa, Janssen Pharmaceutical Companies) for patients with locally advanced or metastatic urothelial carcinoma, with susceptible FGFR3 or FGFR2 genetic alterations, that has progressed during or following platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

    The FDA also approved the therascreen FGFR RGQ RT-PCR Kit developed by Qiagen for use as a companion diagnostic for this therapeutic indication.

    Read the full FDA press release here.

    Posted 4/12/2019



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