FDA Approvals
In cooperation with the Food and Drug Administration (FDA), and as a service to our members, NNECOS will periodically distribute information about newly approved therapies for cancer patients.  This helps FDA to inform oncologists and professionals in oncology-related fields of recent approvals in a timely manner.  Please note the link to the FDA information providing relevant clinical information, contraindications, dosing, and safety.  In providing this information, NNECOS does not endorse any product or therapy and does not take any position on the safety or efficacy of the product or therapy described. If you have questions about billing or reimbursement for these drugs, we recommend that you visit our Regional Reimbursement Page to contact a representative of the manufacturer for assistance.


FDA approves nivolumab plus ipilimumab combination for intermediate or poor-risk advanced renal cell carcinoma

On April 16, 2018, the Food and Drug Administration granted approvals to nivolumab and ipilimumab (Opdivo and Yervoy, Bristol-Myers Squibb Co.) in combination for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma.

https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm604685.htm


FDA approves rucaparib for maintenance treatment of recurrent ovarian, fallopian tube, or primary peritoneal cancer


On April 6, 2018, the Food and Drug Administration approved rucaparib (Rubraca®, Clovis Oncology Inc.), a poly ADP-ribose polymerase (PARP) inhibitor, for the maintenance treatment of recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm603997.htm



FDA Approves blinatumomab
FDA granted accelerated approval to blinatumomab (Blincyto, Amgen Inc.) for the treatment of adult and pediatric patients with B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%. More InformationMarch 29, 2018


FDA approved brentuximab vedotin (Adcetris, Seattle Genetics, Inc.) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy.

FDA  approved brentuximab vedotin (Adcetris, Seattle Genetics, Inc.) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy. More Information.  March 20, 2018 https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm601947.htm



FDA Approves Four-Week Dosing Schedule For Nivolumab

3/6/18

The U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) updating the Opdivo ® (nivolumab) dosing schedule to include 480 mg infused every four weeks (Q4W) for a majority of approved indications.1 This approval will provide health care professionals the flexibility to customize patient care with the option of using the newly approved Q4W (480 mg) flat dose in addition to the previously available option of every two weeks (Q2W) at 240 mg, now available in a new 240 mg vial.1 Opdivo also was approved for a shorter 30-minute infusion across all approved indications.1 Dosing schedule updates for an additional approvedindication for Opdivo may be submitted to the FDA in the future.

https://news.bms.com/press-release/corporatefinancial-news/bristol-myers-squibbs-opdivo-nivolumab-now-first-and-only-fda-


FDA approves abemaciclib

On February 26, 2018, the Food and Drug Administration approved abemaciclib (VERZENIO™, Eli Lilly and Company) in combination with an aromatase inhibitor as initial endocrine-based therapy for postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.  2/26/18

https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm598404.htm

FDA expands approval of Imfinzi to reduce the risk of non-small cell lung cancer progressing

The U.S. Food and Drug Administration today approved Imfinzi (durvalumab) for the treatment of patients with stage III non-small cell lung cancer (NSCLC) whose tumors are not able to be surgically removed (unresectable) and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation). (2/16/18)

https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm601947.htm


FDA approves abiraterone acetate in combination with prednisone for high-risk metastatic castration-sensitive prostate cancer

FDA approved abiraterone acetate (Zytiga, Janssen Biotech Inc.) tablets in combination with prednisone for metastatic high-risk castration-sensitive prostate cancer (CSPC). More Information.  February 7, 2018

Second FDA approval for afatinib 

FDA granted approval to afatinib (Gilotrif, Boehringer Ingelheim Pharmaceutical, Inc.) for a broadened indication in first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have non-resistant epidermal growth factor receptor (EGFR) mutations as detected by an FDA-approved test.   More Information.  January 12, 2018

FDA approves pertuzumab
FDA granted regular approval to pertuzumab (PERJETA, Genentech, Inc.) for use in combination with trastuzumab and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer at high risk of recurrence. More Information.  December 20, 2017FDA approves nivolumab
FDA granted regular approval to the anti-PD1 monoclonal antibody, nivolumab (OPDIVO, Bristol-Myers Squibb Company) for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or in patients with metastatic disease who have undergone complete resection. Nivolumab was previously approved for the treatment of patients with unresectable or metastatic melanoma. More Information.  December 20, 2017 FDA approves bosutinib
FDA granted accelerated approval to bosutinib (BOSULIF, Pfizer Inc.) for treatment of patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML). More Information.   December 19, 2017
FDA approves cabozantinib
FDA granted regular approval to cabozantinib (Cabometyx, Exelixis, Inc.) for treatment of patients with advanced renal cell carcinoma (RCC). More Information.  December 19, 2017.


FDA approves sunitinib malate for adjuvant treatment of renal cell carcinoma


FDA approved sunitinib malate (Sutent, Pfizer Inc.) for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy. More Information November 16, 2017


FDA approves a new first line indication for obinutuzumab
On November 16, 2017, GAZYVA® (obinutuzumab), in combination with chemotherapy followed by GAZYVA monotherapy in patients achieving at least a partial remission, was approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with previously untreated stage II bulky, III or IV follicular lymphoma (FL). The FDA approval letter can be found at https://www.genentech-access.com/gazyva.html.

FDA approves dasatinib for pediatric patients with CML
FDA granted regular approval to dasatinib (SPRYCEL, Bristol-Myers Squibb Co.) for the treatment of pediatric patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase. More Information. November 9, 2017

FDA approves first treatment for certain patients with Erdheim-Chester Disease, a rare blood cancer


The U.S. Food and Drug Administration today expanded the approval of Zelboraf (vemurafenib) to include the treatment of certain adult patients with Erdheim-Chester Disease (ECD), a rare cancer of the blood. Zelboraf is indicated to treat patients whose cancer cells have a specific genetic mutation known as BRAF V600. This is the first FDA-approved treatment for ECD.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm583931.htm

Alectinib approved for (ALK) positive metastatic non-small cell lung cancer (NSCLC)

FDA granted regular approval to alectinib (ALECENSA, Hoffmann-La Roche, Inc./Genentech, Inc.) for treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test. More Information.  November 6, 2017 


FDA approves new treatment for certain advanced or metastatic breast cancers

9/28/17 -The U.S. Food and Drug Administration approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient’s hormones (endocrine therapy). Verzenio is approved to be given in combination with an endocrine therapy, called fulvestrant, after the cancer had grown on endocrine therapy. It is also approved to be given on its own, if patients were previously treated with endocrine therapy and chemotherapy after the cancer had spread (metastasized).https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm578071.htm

FDA grants accelerated approval to pembrolizumab for advanced gastric cancer

On September 22, 2017, the Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co., Inc.) for patients with recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 as determined by an FDA-approved test. Patients must have had disease progression on or after two or more prior systemic therapies, including fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2/neu-targeted therapy.

https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm577093.htm


FDA grants accelerated approval to Opdivo for the Treatment of Hepatocellular Carcinoma Patients Previously Treated with Sorafenib

9/22/17 - The U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection for intravenous use for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. Approval for this indication has been granted under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.1 In the CheckMate -040 trial, 14.3%* (95% CI: 9.2-20.8; 22/154) of patients responded to treatment with Opdivo. The percentage of patients with a complete response was 1.9% (3/154) and the percentage of patients with a partial response was 12.3% (19/154).1 Among responders (n=22), responses ranged from 3.2 to 38.2+ months; 91% of those patients had responses of six months or longer and 55% had responses of 12 months or longer.1

https://www.reuters.com/article/brief-bristol-myers-says-fda-approves-op/brief-bristol-myers-says-fda-approves-opdivo-injection-for-intravenous-use-in-certain-patients-idUSASB0BKMM


FDA Approves Aliqopa (copanlisib) for the treatment of adult patients with relapsed FL who have received at least two prior systemic therapies.

9/14/17 The U.S. Food and Drug Administration granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm576129.htm


FDA Approves Gemtuzumab Ozogamicin for Treatment of Acute Myeloid Leukemia

The U.S. Food and Drug Administration (FDA) today approved gemtuzumab ozogamicin (Mylotarg) for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) whose tumors express the CD33 antigen. The drug was also approved for the treatment of patients aged 2 years and older with relapsed or refractory CD33-positive AML.

http://www.ascopost.com/News/57996


FDA approval brings first gene therapy to the United States

CAR T-cell therapy approved to treat certain children and young adults with B-cell acute lymphoblastic leukemia

The U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States, ushering in a new approach to the treatment of cancer and other serious and life-threatening diseases. (8/30/17)

The FDA approved Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with a form of acute lymphoblastic leukemia (ALL).

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm574058.htm

FDA approves inotuzumab ozogamicin for relapsed or refractory B-cell precursor ALL


FDA approved inotuzumab ozogamicin (BESPONSA,, Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc.) for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).   August 17, 2017. More Information: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm572133.htm

FDA approves treatment for chronic graft versus host disease

The U.S. Food and Drug Administration today expanded the approval of Imbruvica (ibrutinib) for the treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more treatments. This is the first FDA-approved therapy for the treatment of cGVHD.

https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm569710.htm

FDA grants nivolumab accelerated approval for MSI-H or dMMR colorectal cancer

FDA granted accelerated approval to nivolumab (OPDIVO, Bristol-Myers Squibb Company) for the treatment of patients 12 years and older with mismatch repair deficient (dMMR) and microsatellite instability high (MSI-H) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. August 1, 2017.  More Information: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm569366.htm


FDA approves rituximab plus hyaluronidase combination

FDA granted regular approval to the combination of rituximab and hyaluronidase human (RITUXAN HYCELA, Genentech Inc.) for adult patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia.  June 22, 2017. https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm564235.htm


FDA approves ceritinib for NSCLC

FDA granted regular approval to ceritinib (ZYKADIA, Novartis Pharmaceuticals Corp.) for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test. More Information. May 26, 2017


FDA grants accelerated approval to pembrolizumab for first tissue/site agnostic indication

FDA granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co.) for adult and pediatric patients with unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options or with MSI-H or dMMR colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. May 23, 2017.  

More Information: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm560040.htm

Pebrolizumab (Keytruda): Advanced or Metastatic Urothelial Carcinoma
On May 18, 2017, the U.S. FDA granted regular approval to pembrolizumab (KEYTRUDA, Merck and Co., Inc.) for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. . More Information: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm559300.htm

FDA grants accelerated approval to pembrolizumab for NSCLC

On May 10, 2017, the U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA®, Merck and Co., Inc.) in combination with pemetrexed and carboplatin for the treatment of patients with previously untreated metastatic non-squamous non-small cell lung cancer (NSCLC). More information.

FDA grants accelerated approval to avelumab for urothelial carcinoma

The U.S. Food and Drug Administration granted accelerated approval to avelumab (BAVENCIO, EMD Serono, Inc.) for patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. May 9, 2017 More Information: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm557162.htm

FDA approves brigatinib

On April 28, 2017, the U.S. Food and Drug Administration granted accelerated approval to brigatinib (ALUNBRIG tablets, Takeda Pharmaceutical Company Limited, through its wholly owned subsidiary ARIAD Pharmaceuticals, Inc.) for the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.

https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm555841.htm

FDA approves atezolizumab

The FDA approved Tecentriq (atezolizumab) as a first-line treatment for people with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin chemotherapy. The Genentech press release including Important Safety Information is linked here


FDA Approves avelumab

U.S. Food and Drug Administration granted accelerated approval to avelumab (BAVENCIO, EMD Serono, Inc.) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). Avelumab is a programmed death-ligand 1 (PD-L1) blocking human IgG1 lambda monoclonal antibody. This is the first FDA-approved product to treat this type of cancer. March 23, 2017. More Information: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm547965.htm


FDA Approves pembrolizumab

The U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA), Merck and Co., Inc.) for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or those who have relapsed after three or more prior lines of therapy. March 14, 2017. 

More Information: https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm546893.htm


FDA Approves ribociclib
FDA approved ribociclib (KISQALI, Novartis Pharmaceuticals Corp.), a cyclin-dependent kinase 4/6 inhibitor, in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. March 13, 2017.     
More Information:  https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm546438.htm

FDA Approves lenalidomide

FDA approved lenalidomide (Revlimid, Celgene Corp.) as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant.  February 22, 2017.  More Informationhttps://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm542791.htm

FDA Approves Nivolumab for Treatment of Urothelial Carcinoma

February 2, 2017, the U.S. FDA granted accelerated approval to nivolumab (OPDIVO, Bristol-Myers Squibb Company) for treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with a platinum-containing chemotherapy.   February 2, 2017. More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm539646.htm

 

FDA Approves ibrutinib for MZL

January 19, 2017, the U.S. Food and Drug Administration (FDA) approved Imbruvica (ibrutinib) for the treatment of patients with relapsed/refractory (R/R) marginal zone lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.1 This indication is approved under accelerated approval based on overall response rate (ORR), and continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial. 

https://www.drugs.com/newdrugs/u-s-fda-approves-imbruvica-ibrutinib-first-specifically-indicated-relapsed-refractory-marginal-zone-4476.html

FDA Approves rucaparib

FDA granted accelerated approval to rucaparib (RUBRACA, Clovis Oncology, Inc.) for treatment of patients with deleterious BRCA mutation (germline and/or somatic) associated advanced ovarian cancer who have been treated with two or more chemotherapies.  December 19, 2016.  More Information: http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm533891.htm

FDA Approves Avastin in combination with chemotherapy for psOC

The FDA granted approval to Avastin in combination with chemotherapy for the treatment of platinum-sensitive recurrent ovarian cancer (psOC), representing the first new treatment option for women with psOC in the U.S. in more than a decade [press release].

Ovarian cancer causes more deaths than any other gynecological cancer in the U.S., and in 2016, about 22,200 women will be diagnosed with ovarian cancer in the U.S. and about 14,200 will die from the disease. Women with ovarian cancer are considered to have “platinum-sensitive” disease if a relapse occurs six months or longer following the last treatment with a platinum-based chemotherapy. About half of those who relapse after initial treatment – over 8,000 women – will have psOC.

With today’s approval, Avastin is now approved in the U.S. for nine distinct uses across six different types of cancer including two types of gynecological cancer.

Read more. 


To submit FDA approvals for posting consideration, forward to info@nnecos.org.

Northern New England Clinical Oncology Society
P.O. Box 643
Sandown, NH 03873-0643
Telephone (603) 887-1948
info@nnecos.org

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