London Cancer New Drugs Group. February London Cancer New Drugs Group (LCNDG) Work Plan for the London Cancer Drugs Fund list.

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1 February 2013 London Cancer New s Group (LCNDG) Work Plan for the London Cancer s Fund London Cancer s Fund List This Cancer s Fund (CDF) list of medicines and s is in two parts. 1. The standard list of medicines and indications which for which a CDF application form is required. Application is made to the relevant Cancer Network Management team using drug/indication specific application forms. 2. Near off-label indication applications will be reviewed by the London Cancer s Fund Panel, prior to approval. Application is made to the relevant Cancer Network Management Team who will co-ordinate the panel review. A generic Near off-label form is used for such applications. The Dynamic list and LCNDG workplan This work plan provides the list of medicines and indications, their current NICE, LCNDG and CDF and a schedule for when the LCNDG will discuss. The list will be reviewed at each of the bi-monthly LCNDG meetings and changes made as appropriate, as medicines and indications are added to and removed from the CDF Please note: Work is underway to converge each of ten local CDF lists across the country into a single. It is understood that the will be available from the April 2013, until this work is complete it is not possible to put dates for review against each line within this work plan. LCNDG CDF Workplan V13.0 February 2013 Page 1 of 5

2 s on CDF list and remaining on NICE timetable for review & Carboplatin and Paclitaxel Ipilimumab Ruxolitinib Vemurafenib 1st line advanced (stage IIIc/IV) Ovarian cancer, either suboptimally debilked at primary or delayed primary surgery, or not suitable for debulking surgery. Advanced (unresectable or metastatic) melanoma in adults who have received prior therapy. 2nd line Myelofibrosis in patients not achieving a response to current therapy 1 st, 2 nd and subsequent line symptomatic unresectable StIIIC or IV Metastatic melanoma with BRAF V600E mutation In progress, due April 13 Data now published, LCNDG reviewed March 2012, for addition list TA 268 Positive Dec12 LCNDG review discussed September 2011, approved for CDF list In progress. Due Jun 13 and evidence fully published, ranked in order of prioritisation score Vandetanib Bortezomib First line advanced aggressive symptomatic metastatic medullary thyroid cancer First line treatment for myeloma patients for whom transplant is considered unsuitable LCNDG reviewed Sept 12, for addition list, for patients where treatment initiated post licence, i.e. after 24th August 2012 TA 269 Positive Dec12 LCNDG reviewed May 12, for addition of 2 nd and subsequent line treatment, for addition list TA228 recommended but ICERs were with different combinations Pazopanib Third line Metastatic non adipocytic soft tissue sarcoma Everolimus and Second line hormone receptor-positive, HER2/neu negative LCNDG reviewed Nov 2012, for exemestane advanced breast cancer, in combination with exemestane, in Due July 2013 addition list postmenopausal women without symptomatic visceral disease after recurrence or progression following a nonsteroidal aromatase inhibitor. Lenalidomide First relapse myeloma for patients who have TA171 negative previously received bortezomib Brentuximab Abiraterone Relapsed or refractory CD30 positive Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT) or following at least two prior therapies when ASCT or multiagent chemotherapy is not a treatment option. In addition to relapsed or refractory systemic anaplastic large cell lymphoma (salcl) Follicular lymphoma as monotherapy in patients who have progressed during, or within 6 months following treatment with rituximab or a rituximab containing regimen In combination with prednisolone for metastatic castrate resistant prostate cancer, in patients without visceral disease, who are asymptomatic or minimally symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated. TA206 terminated, no evidence submitted by manufacturer, but resubmission planned TA in development - Due Nov 2013 Due November /04/ /09/2011 Remove from CDF list 12/03/ /09/ /06/2012 Remove from CDF list 12/03/ /11/2012 LCNDG CDF Workplan February 2013 Page 2 of 5

3 Pemetrexed Vinflunine First line platinum-sensitive epithelial ovarian cancer (primary peritoneal or fallopian tube cancer) relapse in combination with gemcitabine and carboplatin until progression monotherapy for the maintenance treatment of locally advanced or metastatic non-squamous NSCLC, following induction with pemetrexed and cisplatin. Second line advanced or metastatic transitional cell carcinoma of the urothelial tract Due June 2013 Due June 2013 and equivalent/non-inferior, ranked in order of prioritisation score Tegafur,gimeraci l and oteracil - referred to in literature as S1 Degarelix First line palliative advanced gastric cancer in combination with cisplatin, where standard chemotherapy not possible due to capecitabine toxicity or cardiac toxicity advanced hormone-dependent prostate cancer induction and maintenance where PSA >20 FAD2 negative Nov 12, for inclusion on National CDF Due date TBC Reviewed by LCNDG Jan 2013, Considered not suitable for CDF Axitinib Paclitaxel albumin (Abraxane) As an option for 2nd line advanced renal cell carcinoma with progression after TKI or cytokine As substitute for docetaxel/ paclitaxel for breast cancer therapy in the event of documented hypersensitivity reaction. Off-label/never to be, ranked in order of prioritisation score Rituximab Paclitaxel, cisplatin + gemcitabine Imatinib Maintenance post response to 1st line therapy in Mantle Cell lymphoma ACD negative Dec 12, Due May 2013, early Breast cancer use, would be off-label First line transitional cell carcinoma of bladder Locally advanced/metastatic Chordoma Relapsed/refractory CLL in combination with rituximab in patients refractory to fludarabine based therapy with rituximab for relapsed indolent B-cell and Mantle Cell lymphoma including Relapsed/ refractory Waldenstrőm s macroglobulinaemia 4th & subsequent line (earlier if patient ineligible for other novel therapies) relapsed/refractory myeloma for inclusion on National CDF LCNDG CDF Workplan February 2013 Page 3 of 5

4 single agent Anti-Thymocyte Globulin (Horse)-ATGAM High grade Glioma progressing after Temozolamide and PCV TA suspended due to CHMP opinion Nonegative opinion by CHMP. Company have not resubmitted aplastic anaemia Un Reviewed by LCNDG Jan 2013, supported by the group, but as this is a non-cancer indication, not considered not suitable for CDF Published and not, ranked by due date of licence Pertuzumab Lenalidomide Visomodegib Enzalutamide Afatinib First line HER2 positive metastatic or locally recurrent unresectable breast cancer, previously untreated or who have relapsed post adjuvant treatment First line transfusion dependent anaemia due to low or Int-1 risk Myelodysplastic syndrome with 5q minus cytogenetic abnormality, with or without additional cytogenetic abnornalities Basal cell carcinoma locally advanced disease for whom there is no treatment lft or only very mutilating surgery or patients with metastatic disease As an option for Prostate post docetaxel- No evidence submitted for sequential use with abiraterone in this setting NSCLC after clinical benefit from 1st generation TKI Unpublished, ranked by due date of licence Crizotinib Second and subsequent line, anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). Ponatinib with rituximab as an option for first-line advanced indolent non-hodgkin's and Mantle cell lymphoma Third and subsequent line CML: failure of 2nd line therapy and presence of T315I mutation TA in development- Due Nov 2013 TA in development (pts with RBC transfusion dependence)- Due Aug 2013 TA suspended Due July 2013 TA in development- Due Oct 2013 Q Q Q Q Q (conditional marketing authorisatio n) 2012 Q for inclusion on National CDF LCNDG reviewed Nov 2012, for addition list 30/11/2012 A conditional Marketing Authorisation is granted to a medicinal product that fulfils an unmet clinical need when the benefit to public health of immediate availablility outweighs the risk inherent in the fact that additional data are still required. LCNDG CDF Workplan February 2013 Page 4 of 5

5 Radium 223 Regorafenib Rare indication Symptomatic castration refractory prostate cancer First or second line platinum-resistant ovarian cancer( primary peritoneal, fallopian tube cancer) relapse (1st or second line) in combination with pegylated liposomal doxorubicin, weekly paclitaxel or topotecan until progression Third and subsequent line metastatic colorectal cancer who have been previously treated with (or not considered candidates for) fluoropyrimidine based chemotherapy, an anti-vegf therapy, and if KRAS wild-type an anti-egfr therapy Q Q Sirolimus Malignant Perivascular Epithelial Cell Tumours ( PEComa) Reviewed by LCNDG Jan 2013, Considered not suitable for CDF LCNDG CDF Workplan February 2013 Page 5 of 5

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