Approval of PADCEV™ (enfortumab vedotin‑ejfv) by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC)

We are excited to announce the approval of PADCEV™ (enfortumab vedotin‑ejfv) by the U.S. Food and Drug

Administration (FDA) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC)

who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor,

and a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.

This indication is approved under accelerated approval based on tumor response rate. Continued approval may be

contingent upon verification and description of clinical benefit in confirmatory trials.

PADCEV is now the first treatment option FDA approved for adult patients in this post platinum, post PD-1/L1

inhibitor setting.

Important Safety Information

Warnings and Precautions

Hyperglycemia occurred in patients treated with PADCEV, including death and diabetic ketoacidosis (DKA), in those

with and without pre-existing diabetes mellitus. The incidence of Grade 3-4 hyperglycemia increased consistently

in patients with higher body mass index and in patients with higher baseline A1C. In one clinical trial, 8% of patients

developed Grade 3-4 hyperglycemia. Patients with baseline hemoglobin A1C ≥8% were excluded. Closely monitor

blood glucose levels in patients with, or at risk for, diabetes mellitus or hyperglycemia. If blood glucose is elevated

(>250 mg/dL), withhold PADCEV.

Peripheral neuropathy (PN), predominantly sensory, occurred in 49% of the 310 patients treated with PADCEV in

clinical trials; 2% experienced Grade 3 reactions. In one clinical trial, peripheral neuropathy occurred in patients treated

with PADCEV with or without preexisting peripheral neuropathy. The median time to onset of Grade ≥2 was 3.8 months

(range: 0.6 to 9.2). Neuropathy led to treatment discontinuation in 6% of patients. At the time of their last evaluation,

19% had complete resolution, and 26% had partial improvement. Monitor patients for symptoms of new or worsening

peripheral neuropathy and consider dose interruption or dose reduction of PADCEV when peripheral neuropathy

occurs. Permanently discontinue PADCEV in patients that develop Grade ≥3 peripheral neuropathy.

Ocular disorders occurred in 46% of the 310 patients treated with PADCEV. The majority of these events involved

the cornea and included keratitis, blurred vision, limbal stem cell deficiency and other events associated with dry eyes.

Dry eye symptoms occurred in 36% of patients, and blurred vision occurred in 14% of patients, during treatment

with PADCEV. The median time to onset to symptomatic ocular disorder was 1.9 months (range: 0.3 to 6.2). Monitor

patients for ocular disorders. Consider artificial tears for prophylaxis of dry eyes and ophthalmologic evaluation if ocular

symptoms occur or do not resolve. Consider treatment with ophthalmic topical steroids, if indicated after an ophthalmic

exam. Consider dose interruption or dose reduction of PADCEV for symptomatic ocular disorders.

Please see additional Important Safety Information on the next page and click here for Full Prescribing Information.

Daiichi Sankyo and AstraZeneca

Daiichi Sankyo and AstraZeneca announced that the US Food and Drug Administration (FDA) approved ENHERTU® (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. 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.

For more information, please visit ENHERTUhcp.com

New St. Gallen International Breast Cancer Guidelines Recommend Oncotype DX Breast Recurrence Score® Test to Guide Chemotherapy for Node-negative and Node-positive Early-stage Breast Cancer

New St. Gallen International Breast Cancer Guidelines Recommend Oncotype DX Breast Recurrence Score® Test to Guide Chemotherapy for Node-negative and Node-positive Early-stage Breast Cancer

- Guidelines include TAILORx-defined cutoff of 26 for determining chemotherapy benefit in node-negative disease, and recommend that more women with limited nodal involvement may avoid chemotherapy

- Oncotype DX® test recommended based on prospective landmark TAILORx and German PlanB studies, recognized as key scientific and clinical research innovations of the past two years

- Genomic testing strongly endorsed by vast majority of panelists

REDWOOD CITY, Calif., Aug. 21, 2019  Genomic Health today announced that, based on results from the prospective TAILORx1 and PlanB2 studies, the 16thSt. Gallen International Breast Cancer Conference Expert Panel has recommended the Oncotype DX Breast Recurrence Score® test to guide chemotherapy treatment use for patients with hormone-receptor positive, HER-2 negative early-stage breast cancer with and without lymph node involvement (up to three positive nodes).

In particular, the panelists recognized the value of the landmark TAILORx study results and noted that women with node-negative cancers and Recurrence Score® results ≤25 do not need chemotherapy.3 This group represents up to about 80% of patients who may be safely spared chemotherapy. The Breast Recurrence Score test also identifies those patients (with results of 26 to 100) who may receive a life-saving benefit from chemotherapy.

In the new guidelines, genomic testing with robust validation through prospective, randomized trials is preferred over clinical-pathological features "for basing the critical yes/no chemotherapy decision." 4 Results from a recently published subset analysis of the prospective, randomized TAILORx study5 showed that only the Breast Recurrence Score test is predictive of chemotherapy benefit; clinical and pathological features are only prognostic and do not provide predictive information.

FDA Grants Accelerated Approval for POLIVY™

On June 10, 2019, the US Food and Drug Administration (FDA) granted accelerated approval for POLIVY™ (polatuzumab vedotin-piiq) in combination with bendamustine and rituximab for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, after at least 2 prior therapies.

POLIVY Access Solutions is your resource for access and reimbursement support after POLIVY is prescribed. We can helpyour patients and practice by providing:

  • Benefits investigations (BIs)
  • Prior authorization (PA) resources
  • Information about authorized specialty distributors
  • Sample billing and coding information
  • Resources for appeals
  • Referrals to co-pay support
  • Patient assistance options

A list of authorized specialty distributors is available at Genentech-Access.com/POLIVY.

For more information about POLIVY patient access, please call your POLIVY Access Solutions Case Manager at (888) 249-4918.

POLIVY Sample Coding and Distribution Brochure

POLIVY Master USPI

New FDA approval for ROZLYTREK™

Genentech is excited to share the news of a new FDA approval. ROZLYTREK™ (entrectinib) is now FDA approved for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive.

ROZLYTREK is also FDA approved for the treatment of adult and pediatric patients 12 years of age and older with solid tumors that:

  • have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation,
  • are metastatic or where surgical resection is likely to result in severe morbidity, and 
  • have either progressed following treatment or have no satisfactory alternative 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.

Please see the ROZLYTREK Day 1 Letter, as well as the full Prescribing Information, for additional Important Safety Information. This announcement includes patient assistance information, dosing, information regarding billing, coding, and distribution. Please forward to relevant stakeholders or departments in your organization.

ALECENSA & ROZLYTREK Distribution Quick Ref Card

ROZLYTREK Approved USPI

New FDA Approval for KEYTRUDA

Merck is pleased to announce that KEYTRUDA, in combination with platinum and fluorouracil (FU), has been approved by the FDA for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA has also been approved by the FDA as a single agent for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) ≥1] as determined by an FDA-approved test.

PD-L1 diagnostic testing is required prior to initiating monotherapy with KEYTRUDA in patients with metastatic or with unresectable, recurrent HNSCC.

Prior Indication:

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

This prior indication has not changed.

FDA=Food and Drug Administration; PD-L1=programmed death ligand 1

Before prescribing KEYTRUDA® (pembrolizumab), please read the Prescribing Information.
The Medication Guide also is available.

New FDA Approval for KEYTRUDA

Merck is pleased to announce that KEYTRUDA has been approved by the FDA for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line 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 confirmatory trials.

PD-L1 diagnostic testing is not required prior to initiating treatment with KEYTRUDA in these patients

FDA=Food and Drug Administration; PD-L1=programmed death ligand 1

Click Here to read the FDA Approval Notice

Before prescribing KEYTRUDA® (pembrolizumab), please read the Prescribing Information.

The Medication Guide also is available.