Below you will find relevant news links and information:
ASCO Newsletter - June 2017
Newly approved information on therapies for cancer patients
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Keytruda: Now Approved for 200-mg fixed-dose administration in patients with unresectable or metastatic melanoma.
Please see the attached information from Merck. If you have any questions, please contact me directly.
Keytruda: Now FDA Approved in Combination with Carboplatin/Pemetrexed
Keytruda, in combination with pemetrexed and carboplatin, is indicated for the first-line treatment of patients with metastatic non squamous non-small cell lung cancer (NSCLC). This indication is approved under accelerated approval based on tumor response rate and progress-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
FDA Approval of ALUNBRIG
Takeda Oncology is proud to announce the FDA Approval of ALUNBRIG, 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. Please see accompanying prescription information and approval letter.
TECENTRIQ® (atezolizumab) is NOW FDA APPROVED
for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy. TECENTRIQ is also approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following any platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant chemotherapy. 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 confirmatory trials. Please see the attached announcement for additional information, including NDC and ICD-10 codes.
Please see accompanying full Prescribing Information for additional Important Safety Information.
EMD Serono and Pfizer announced the approval of BAVENCIO® (avelumab) Injection on (insert approval date). The following information is for State Society review:
Approval Information: Click here
Full Prescribing Information: Click here
Keytruda Now Approved for Refractory or Relapsed Classical Hodgkin Lymphoma (cHL).
Keytruda is indicated for the treatment of adult and pediatric patients with refractory CHL or who have relapsed after three or more prior lines of therapy. 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.
Prescribing Information. Medication Guide
DEA Eliminates Grace Period for Registration Renewal
Through a notice on its website, the Drug Enforcement Administration (DEA) recently announced significant changes to its registration renewal process. Effective January 1, 2017, the DEA is eliminating the informal grace period which the agency has previously allowed for registrants to renew their registrations. Only one renewal notice will be sent to each registrant’s “mail to” address approximately 65 days prior to the expiration date; no other reminders to renew the DEA registration will be provided. The notice also advises that online capability to renew a DEA registration after the expiration date will no longer be available, and that failure to file a renewal application by midnight EST of the expiration date will result in the “retirement” of the registrant’s DEA number. The original DEA registration will not be reinstated. In addition, paper renewal applications will not be accepted the day after the expiration date. If DEA has not received the paper renewal application by the day of the expiration date, mailed in renewal applications will be returned and the registrant will have to apply for a new DEA registration.
The American Medical Association (AMA) has strongly expressed its concerns to DEA about this change in policy and the problems it could create for both patients and their physicians through letters sent Friday, December 9 to DEA Acting Administrator Charles Rosenberg and Louis Milione (Assistant Administrator for Diversion Control). These letters urged DEA to reverse the change to the renewal process.
Assignment of a product-specific Healthcare Common Procedure Coding System (HCPCS) code for Portrazza® (necitumumab) for injection.
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You're Invited to a Satellite Broadcast Web Program
Presentation on New Data vs. Bicalutamide
Featuring: Dr. Neal Shore, Atlantic Urology Clinics, Myrtle Beach, SC
Monday, November 14, 2016- 7:00pm EST and 7:30pm MT
Wednesday, November 16, 2016 - 7:00pm EST and 7:30pm MT
Click to download postcard
Click to download the new clinical trial communication flyer
LARTRUVO approved by FDA
On October 19, 2016, the US Food and Drug Administration (FDA) approved LARTRUVO™ (olaratumab) injection, 10 mg/mL solution. 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. This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.
Click here for full Prescribing Information. For more information, please visit www.lartruvo.com/HCP.