WELCOME TO THE DRUG APPROVALS PAGE

Below you will find information and links to new cancer therapies or recent FDA changes of approvals of medication offered by NOS Corporate Members!

New Drug Approvals:  

Click links below to be directed to product site or PI. Drugs and Products will stay online for 12 months from approval date.  Updated 10/20/16 SD

 

PLEASE SEE THE INFORMATION BELOW REGARDING UPDATED NEW DRUGS AND NEW INDICATIONS OF N.O.S. CORPORATE MEMBERS

*For your convenience just Click on name of drug below to be directed to company website for P.I. and more information.



Corporate Member Merck - NEW Formulation

EMEND™ (fosaprepitant):

FDA approval for a new formulation of EMEND for injection that has a lower concentration of edetate disodium (EDTA), an inactive ingredient.  This new formulation (5.4 mg EDTA, NDC 0006-3061-00) will replace the existing formulation (18.8 mg EDTA, NDC 0006-3941-32).  The purpose of this formulation change is to support ongoing regulatory activities for EMEND.   More Information 7/2017


Corporate Member AstraZeneca - NEW Approval

IMFINZI™ (durvalumab):

The US Food and Drug Administration (FDA) has granted accelerated approval to IMFINZI™ (durvalumab) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery.

More Information 6/2017

Corporate Member Takeda - NEW Indication

ALUNBRIG (brigatinib): 

Takeda Oncology is proud to announce the FDA approval of ALUNBRIG (brigatinib), a kinase inhibitor indicated for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

 More Information 6/2017



Corporate Member Merck - NEW Indication

KEYTRUDA (Pembrolizumab): 

The U.S. Food and Drug Administration (FDA) has approved two new indications for KEYTRUDA® (pembrolizumab), the company’s anti-PD-1 therapy, for certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer. In the first-line setting, KEYTRUDA is now approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. In the second-line setting, KEYTRUDA is now approved for the treatment of 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. KEYTRUDA is approved for use in these indications at a fixed dose of 200 mg every three weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.

 More Information 6/2017



Corporate Member AstraZeneca - NEW Indication

TAGRISSO (Osimertinib):                                                                             

   The US Food and Drug Administration (FDA) granted full approval for TAGRISSO® (osimertinib) 80mg once-daily tablets, for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed on or after an EGFR tyrosine kinase inhibitor (TKI) therapy. The full approval is based the randomized, Phase III AURA3 trial, where TAGRISSO significantly improved progression-free survival (PFS) versus platinum-based doublet chemotherapy, providing 10.1 months of median progression-free survival compared to 4.4 months from chemotherapy (hazard ratio 0.30; 70% risk reduction; 95% Confidence Interval [CI]: 0.23; 0.41; P<0.001). Additionally, TAGRISSO demonstrated efficacy in patients with measurable central nervous system (CNS) lesions at baselineTAGRISSO was granted Fast Track, Breakthrough Therapy and Priority Review by the FDA, and received Accelerated Approval for this indication in 2015, based on tumor response rate and duration of response.

More Information 6/2017


Corporate Member Merck - NEW Indication

KEYTRUDA (Pembrolizumab): 

is indicated for the treatment of 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 colorectal cancer that has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved 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. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

More Information 6/2017


Corporate Member Merck - NEW Indication

KEYTRUDA (Pembrolizumab): 

Merck is pleased to announce that KEYTRUDA is now the only anti–PD-1 approved in combination with carbo/pem for the first line treatment of patients with nonsquamous metastatic NSCLC (mNSCLC) irrespective of PD-L1 expression. KEYTRUDA is also the only anti–PD-1 approved as first-line monotherapy for patients with nonsquamous and squamous mNSCLC whose tumors have high PD-L1 expression (TPS ≥50%) and are negative for EGFR and ALK genomic tumor aberrations.

 More Information 6/2017



Corporate Member Genentech - NEW Indication

TECENTRIQ (Atezolizumab)

TECENTRIQ for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin chemotherapy. TECENTRIQ was previously approved for people with locally advanced or mUC who have disease progression during or following any platinum-containing chemotherapy, or within 12 months of receiving chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). It is not known if TECENTRIQ is safe and effective in children. Bladder cancer is the most common type of urothelial carcinoma, and up to half of all people with the advanced form of the disease are unable to receive cisplatin chemotherapy as an initial treatment and therefore have a high unmet medical need. Urothelial carcinoma also includes cancers of the urethra, ureters and renal pelvis.  More Information
4/2017



Corporate Member Celgene - NEW Indication                            

Revlimid (lenalidomide):
REVLIMID is indicated as maintenance therapy in patients with multiple myeloma (MM) following autologous hematopoietic stem cell transplantation (auto-HSCT). REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials. More Information 4/2017


Corporate Member EMD Serono - NEW Approval

BAVENCIO® (avelumab):

BAVENCIO is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC). More Information 3/2017


Corporate Member Merck - NEW Indication

KEYTRUDA (Pembrolizumab):                                                                KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory cHL, or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. More Information 3/2017


Corporate Member Eli Lilly - NEW Approval

LARTRUVO (olaratumab):
LARTRUVO is indicated, in combination with doxorubicin, for the treatment of adult patients with soft tissue sarcoma (STS) with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery. More Information 11/2016T


Corporate Member Merck - EXPANDED INDICATION

KEYTRUDA (Pembrolizumab): 

KEYTRUDA is indicated for the first-line treatment of patients with metastatic non–small cell lung cancer (mNSCLC) whose tumors have high PD-L1 expression [tumor proportion score (TPS) ≥50%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. More Information 11/2016


Corporate Member Genentech - NEW Approval

TECENTRIQ (Atezolizumab)

TECENTRIQ is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving TECENTRIQ. More Information
10/2016

Corporate Member Merck - Expanded Indication

EMEND (fosaprepitant dimeglumine)

EMEND® is a substance P/neurokinin 1 (NK1) receptor antagonist. EMEND for oral suspension is indicated in combination with other antiemetic agents, in patients 6 months of age and older for prevention of:
  • acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin (1.1)
  •  nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy(MEC)
Prescribing Information
Patient Information
Instructions for Use
 8/2016


Corporate Member Merck - EXPANDED INDICATION

KEYTRUDA (Pembrolizumab): 

For Patients with Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma with Disease Progression on or After Platinum-Containing Chemotherapy. More information can be found here. 8/2016T



Nebraska Oncology Society
c/o Nebraska Medical Association
Sarah Dunbar
Executive Director
233 South 13th Street Suite 1200
Lincoln, NE 68508
sarahd@nebmed.org (email)
402-474-4472 (phone)
402-474-2198 (fax)

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