On October 2, 2017 Seattle Genetics, Inc. (NASDAQ:SGEN) reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to ADCETRIS (brentuximab vedotin) in combination with chemotherapy for the frontline treatment of patients with advanced classical Hodgkin lymphoma (Press release, Seattle Genetics, OCT 2, 2017, View Source [SID1234520737]). The positive topline results of the phase 3 ECHELON-1 clinical trial were announced in June 2017 and full data will be presented at the upcoming American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting, December 9-12, 2017 in Atlanta, Georgia. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical Hodgkin lymphoma. ADCETRIS is being evaluated globally as the foundation of care for CD30-expressing lymphomas in more than 70 corporate- and investigator-sponsored clinical trials. ADCETRIS is currently not approved as a frontline therapy for Hodgkin lymphoma.

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The FDA’s Breakthrough Therapy Designation is intended to expedite the development and review of promising drug candidates for serious or life-threatening conditions. It is based upon clinical evidence of substantial improvement over existing therapies on one or more clinically significant endpoints.

“The phase 3 ECHELON-1 study that supports the Breakthrough Therapy Designation for ADCETRIS in combination with chemotherapy showed superior activity versus the standard of care chemotherapy regimen in the treatment of frontline advanced classical Hodgkin lymphoma patients,” said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “The decision by the FDA to grant this designation recognizes the need for new options that can change the care of people with newly diagnosed advanced Hodgkin lymphoma. The designation supports our goal to make ADCETRIS available to patients in this setting as soon as possible. We look forward to presenting the data from our phase 3 ECHELON-1 trial at the upcoming ASH (Free ASH Whitepaper) annual meeting and intend to submit a supplemental Biologics License Application to the FDA before the end of 2017.”

This Breakthrough Therapy Designation was based on data from the phase 3 ECHELON-1 clinical trial. The ECHELON-1 study evaluated a combination of ADCETRIS plus AVD (Adriamycin, vinblastine, dacarbazine) compared to a recognized standard of care chemotherapy regimen in previously untreated advanced classical Hodgkin lymphoma. The ECHELON-1 study met its primary endpoint of a statistically significant improvement in modified progression-free survival (PFS) of the ADCETRIS containing regimen versus the control arm as assessed by an Independent Review Facility (hazard ratio=0.770; p-value=0.035). The two-year modified PFS rate for patients in the ADCETRIS arm was 82.1 percent compared to 77.2 percent in the control arm. Interim analysis of overall survival, the key secondary endpoint, also trended in favor of the ADCETRIS plus AVD arm. The safety profile of ADCETRIS+AVD in the ECHELON-1 trial was consistent with that known for the single-agent components of the regimen.

ECHELON-1 Phase 3 Clinical Trial Design

The randomized, open-label, phase 3 trial is investigating ADCETRIS plus AVD versus ABVD (Adriamycin, bleomycin, vinblastine, dacarbazine) as frontline therapy in patients with advanced classical Hodgkin lymphoma. The primary endpoint is modified PFS per Independent Review Facility assessment using the Revised Response Criteria for Malignant Lymphoma. Modified PFS is defined as the time to progression, death or receipt of additional anticancer therapy for patients who are not in complete response after completion of frontline therapy per Independent Review Facility. This endpoint was chosen as it provides a clearer picture of the efficacy of frontline chemotherapy and eliminates the confounding impact of salvage and consolidation chemotherapies and radiotherapy. Secondary endpoints include overall survival, complete remission and safety. The multi-center trial was conducted in North America, Europe, South America, Australia, Asia and Africa. The study enrolled 1,334 patients who had a histologically-confirmed diagnosis of Stage III or IV classical Hodgkin lymphoma and had not been previously treated with systemic chemotherapy or radiotherapy. The ECHELON-1 trial is being conducted under a Special Protocol Assessment (SPA) agreement from the FDA and the trial also received European Medicines Agency (EMA) scientific advice.

Please see Important Safety Information at the end of this press release.

About Classical Hodgkin Lymphoma

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Classical Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. The Reed-Sternberg cell expresses CD30.

About ADCETRIS

ADCETRIS is being evaluated broadly in more than 70 clinical trials, including four phase 3 studies: the ECHELON-1 trial in frontline classical Hodgkin lymphoma from which positive topline results were recently reported, the ongoing ECHELON-2 trial in frontline mature T-cell lymphomas, the completed ALCANZA trial in cutaneous T-cell lymphoma that supported the supplemental BLA with a Prescription Drug User Fee Act (PDUFA) target action date of December 16, 2017, and the recently initiated CHECKMATE 812 trial of ADCETRIS in combination with Opdivo (nivolumab) for relapsed/refractory Hodgkin lymphoma.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-positive tumor cells.

ADCETRIS for intravenous injection has received approval from the FDA for three indications: (1) regular approval for the treatment of patients with classical Hodgkin lymphoma after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (2) regular approval for the treatment of classical Hodgkin lymphoma patients at high risk of relapse or progression as post-auto-HSCT consolidation, and (3) accelerated approval for the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen. The sALCL indication is approved under accelerated approval based on overall response rate. Continued approval for the sALCL indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL in 2013, and non-conditional approval for post-ASCT consolidation treatment of Hodgkin lymphoma patients at increased risk of relapse or progression.

ADCETRIS was granted conditional marketing authorization by the European Commission in October 2012 for two indications: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following autologous stem cell transplant (ASCT), or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) the treatment of adult patients with relapsed or refractory sALCL. The European Commission extended the current conditional marketing authorization of ADCETRIS and approved ADCETRIS for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT.

ADCETRIS has received marketing authorization by regulatory authorities in 67 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See important safety information below.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

On September 29, 2017 Mylan N.V. (NASDAQ, TASE: MYL) reported that the U.S. launch of Imatinib Mesylate Tablets, 100 mg and 400 mg, a generic version of Novartis’s Gleevec Tablets. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which has multiple indications, including for several blood cancers (Press release, Mylan, SEP 29, 2017, View Source [SID1234520708]).

Imatinib Mesylate Tablets, 100 mg and 400 mg, had U.S. sales of approximately $1.7 billion for the 12 months ending July 31, 2017, according to QuintilesIMS.

Mylan is one of the largest suppliers of cancer medicines by volume in the U.S., with a robust oncology portfolio of more than 40 products.

To enhance access for eligible commercially insured patients, Mylan will offer a Savings Card for Imatinib Mesylate Tablets,* which will help reduce a patient’s out-of-pocket costs. The card provides up to $700 off the monthly out-of-pocket costs for the product and is reusable up to 12 times per calendar year. Eligible patients can participate in Mylan’s Savings Card for Imatinib Mesylate Tablets program by registering online at activatethecard.com/imatinib.

Currently, Mylan has 227 ANDAs pending FDA approval, representing approximately $96.2 billion in annual brand sales, according to QuintilesIMS. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing $45.5 billion in annual brand sales, for the 12 months ending July 31, 2017, according to QuintilesIMS. Currently, one out of every 13 prescriptions filled in the U.S. – brand-name or generic – is a Mylan product.

Imatinib Mesylate Tablets are a kinase inhibitor indicated for the treatment of:

Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase

Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP) or in chronic phase (CP) after failure of interferon-alpha therapy

Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL)

Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements as determined with an FDA-approved test

Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation as determined with an FDA-approved test or with c-Kit mutational status unknown

Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown

Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP)

On September 29, 2017 Mylan N.V. (NASDAQ, TASE: MYL) reported that the U.S. launch of Imatinib Mesylate Tablets, 100 mg and 400 mg, a generic version of Novartis’s Gleevec Tablets. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which has multiple indications, including for several blood cancers (Press release, Mylan, SEP 29, 2017, View Source [SID1234520708]).

Mylan (PRNewsfoto/Mylan N.V.)

Imatinib Mesylate Tablets, 100 mg and 400 mg, had U.S. sales of approximately $1.7 billion for the 12 months ending July 31, 2017, according to QuintilesIMS.

Mylan is one of the largest suppliers of cancer medicines by volume in the U.S., with a robust oncology portfolio of more than 40 products.

To enhance access for eligible commercially insured patients, Mylan will offer a Savings Card for Imatinib Mesylate Tablets,* which will help reduce a patient’s out-of-pocket costs. The card provides up to $700 off the monthly out-of-pocket costs for the product and is reusable up to 12 times per calendar year. Eligible patients can participate in Mylan’s Savings Card for Imatinib Mesylate Tablets program by registering online at activatethecard.com/imatinib.

Currently, Mylan has 227 ANDAs pending FDA approval, representing approximately $96.2 billion in annual brand sales, according to QuintilesIMS. Forty-five of these pending ANDAs are potential first-to-file opportunities, representing $45.5 billion in annual brand sales, for the 12 months ending July 31, 2017, according to QuintilesIMS. Currently, one out of every 13 prescriptions filled in the U.S. – brand-name or generic – is a Mylan product.

Imatinib Mesylate Tablets are a kinase inhibitor indicated for the treatment of:

Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase

Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP) or in chronic phase (CP) after failure of interferon-alpha therapy

Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL)

Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements as determined with an FDA-approved test

Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation as determined with an FDA-approved test or with c-Kit mutational status unknown

Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown

Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP)